NIH Adrenal Clinical Trials Updated 6/6/2011

Rank	Status	Study
1	Recruiting	Trial of Vasopressin and Epinephrine to Epinephrine Only for In-Hospital Pediatric Cardiopulmonary Resuscitation Conditions: Cardiopulmonary Arrest;   Cardiac Arrest Interventions: Drug: Vasopressin;   Drug: Epinephrine
2	Recruiting	Test Predicting Adrenal Insufficiency in Volunteers Under Prednisone Treatment Condition: Adrenal Gland Hypofunction Interventions: Procedure: adrenal insufficiency testing;   Drug: prednisone
3	Recruiting	The Bupivacaine Dose Sparing Effect of Intrathecal Epinephrine Condition: Spinal Anesthesia Interventions: Drug: Placebo;   Drug: epinephrine 25;   Drug: Epinephrine 50;   Drug: epinephrine 100;   Drug: Epi 200
4	Recruiting	SPARTACUS: Subtyping Primary Aldosteronism: a Randomized Trial Comparing Adrenal Vein Sampling and Computed Tomography Scan. Condition: Hyperaldosteronism Intervention: Other: Ct-scan or adrenal vein sampling
5	Not yet recruiting	Intranasal Injection Versus Topical Administration of Epinephrin During Endoscopic Sinus Surgery Conditions: Hypertension;   Hypotension;   Tachycardia;   Bradycardia;   Arrhythmia Interventions: Drug: Epinephrin (Intranasal injection);   Drug: Epinephrin (Topical administration)
6	Recruiting	Adrenal Insufficiency in Septic Shock Conditions: Septic Shock;   Acute Adrenal Insufficiency Intervention: Drug: Corticosteroid
7	Recruiting	Performance of 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in the Diagnosis of Indeterminate Adrenal Tumors on Conventional Imaging: A French Prospective Multicentric Study Condition: Adrenal Gland Neoplasms Intervention: Other: FDG-PET scan
8	Unknown †	Prospective Study on the Incidence of Adrenal Crisis in Patients With Chronic Adrenal Insufficiency Condition: Adrenal Insufficiency Intervention:
9	Recruiting	Adrenal Function in Critical Illness Condition: Adrenal Insufficiency Intervention:
10	Recruiting	Adrenal Vein Sampling International Study (AVIS Study) Condition: Hyperaldosteronism Intervention:
11	Recruiting	Epinephrine Inhalation Aerosol USP: For Evaluation Of Efficacy And Safety In Asthma Patients Condition: Asthma Interventions: Drug: Epinephrine inhalation aerosol;   Drug: Placebo;   Drug: epinephrine inhalation aerosol
12	Unknown †	Adrenal Insufficiency in Critical Emergencies in Digestive Diseases Conditions: Digestive Diseases;   Adrenal Insufficiency;   Gastrointestinal Bleeding;   Variceal Bleeding;   Acute Pancreatitis Intervention:
13	Not yet recruiting	Prevalence Study of Adrenal Suppression After Corticosteroids During Chemotherapy. Condition: Adrenal Suppression Intervention: Other: Prevalence study only, no study intervention
14	Recruiting	Adrenal Hyperplasia Among Young People With PCOS Conditions: Adrenal Hyperplasia;   Polycystic Ovarian Syndrome;   Oligomenorrhea;   Obesity;   Hyperandrogenism Intervention:
15	Recruiting	Low-Dose Epinephrine Infusion Tests in Adolescent and Pediatric Patients Condition: Congenital Disorders Intervention: Drug: Epinephrine
16	Recruiting	Evaluation of Molecular Markers in Adrenal Tumors Condition: Adrenal Gland Neoplasms Intervention:
17	Unknown †	Adrenal Function After Living Kidney Donation Conditions: Addison Disease;   Hypoaldosteronism Intervention: Procedure: Laparoscopic hand-assisted donor nephrectomy
18	Recruiting	Adrenal Tumors - Pathogenesis and Therapy Conditions: Adrenal Tumors;   Adrenocortical Carcinoma;   Cushing Syndrome;   Conn Syndrome;   Pheochromocytoma Intervention:
19	Not yet recruiting	A Pilot Study of F-18 Paclitaxel (FPAC) PET for Evaluating Drug Delivery of Solid Tumors in Breast, Lung, Renal, and Adrenal Cancers Conditions: Breast Cancer;   Lung Cancer;   Renal Cancer;   Adrenal Cancer Intervention: Drug: F-18 Paclitaxel (FPAC)
20	Not yet recruiting	The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery Condition: Chronic Sinusitis Interventions: Drug: 1% lidocaine with 1:100,000 adrenaline;   Drug: 1% lidocaine with 1:200,000 adrenaline

21	Recruiting	Study of Intracameral Adrenaline for Pupil Dilation Without Topical Mydriatics in Refractive Cataract Surgery Condition: Cataract Intervention: Drug: adrenalin
22	Recruiting	Study of Adrenal Gland Tumors Condition: Adrenal Gland Neoplasm Intervention:
23	Recruiting	The Effects of Epinephrine in Endotoxemia in Normal Volunteers Condition: Immune System Interventions: Biological: Endotoxin, Lipopolysaccharide, LPS;   Biological: Endotoxin, Lipopolysaccharide, LPS /Epinephrine
24	Unknown †	Does Topical Steroid Treatment Impair the Adrenal Function? Conditions: Hypothalamus-Pituitary-Adrenal Axis Assessement;   Topical Steroid Therapy in Chronic Skin Diseases Intervention:
25	Recruiting	Combination Local Anesthetics Condition: Perioperative Pain Interventions: Drug: 1% Lidocaine with Epinephrine;   Drug: 0.25% Bupivacaine with epinephrine;   Drug: 1% Lidocaine + 0.25% Bupivacaine with Epinephrine;   Drug: 2% Lidocaine + 0.5% Bupivacaine with epinephrine
26	Recruiting	Study Comparing Peri-articular Injection of Bupivacaine With and Without Epinephrine Condition: Osteoarthritis Interventions: Procedure: Peri-articular injection of marcaine/epinephrine;   Procedure: Peri-articular injection of marcaine alone
27	Not yet recruiting	Gluing Lacerations Utilizing Epinephrine Condition: Lacerations Intervention: Drug: LET - Lidocaine Epinephrine Tetracaine
28	Recruiting	Use of Local Analgesia With Epinephrine During Total Hip Arthroplasty (THA) Condition: Arthroplasty, Replacement, Hip Intervention: Drug: ropivacaine, physical serum and adrenalin
29	Recruiting	Relative Adrenal Insufficiency in Preterm Very Low Birth Weight Infants With Shock Condition: Adrenal Insufficiency Intervention:
30	Unknown †	Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Hydrocortisone on Renal and Haemodynamic Function Condition: Cirrhosis With Ascites Interventions: Drug: hydrocortisone;   Drug: dextrose solution 5%
31	Recruiting	Bronchiolitis, Optimal Treatment in Infants and Prognosis Condition: Bronchiolitis Interventions: Drug: Racemic adrenaline;   Drug: Isotonic saline
32	Recruiting	RAD001 in Pheochromocytoma or Nonfunctioning Carcinoid Conditions: Pheochromocytoma;   Extra-Adrenal Paraganglioma;   Non-functioning Carcinoid Intervention: Drug: RAD001
33	Not yet recruiting	Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q4 Condition: Type 1 Diabetes Intervention: Drug: epinephrine
34	Recruiting	Effect of Epinephrine/ Phenylephrine for Preventing the Postreperfusion Syndrome During Reperfusion in Liver Transplantation Condition: Hypotension After Reperfusion in Liver Transplantation Interventions: Drug: phenylephrine;   Drug: epinephrine;   Drug: placebo control
35	Recruiting	Safety Study Evaluating the Adrenal Suppression Potential of Product 0405 in Pediatric Subjects With Atopic Dermatitis Condition: Atopic Dermatitis Intervention: Drug: Product 0405
36	Recruiting	Merits of Continuous Paravertebral Block in the Management of Renal/Adrenal Surgery by Laparotomy Condition: Patient Scheduled for Renal and/or Adrenal Surgery Intervention: Procedure: Continuous Paravertebral block
37	Not yet recruiting	Adrenalectomy Versus Follow-up in Patients With Subclinical Cushings Syndrome Condition: Adrenal Tumour With Mild Hypercortisolism Intervention: Procedure: Adrenalectomy
38	Unknown †	Role of the Protein Osteoprotegerin in the Bone Health of Women With Congenital Adrenal Hyperplasia Condition: Adrenal Hyperplasia, Congenital Intervention:
39	Recruiting	Gene Polymorphisms Influencing Steroid Synthesis and Action Conditions: Disorders of Sex Development;   Congenital Adrenal Hyperplasia;   Congenital Adrenal Hypoplasia;   Adrenal Insufficiency;   Mineralocorticoid Deficiency;   Intersex Intervention:
40	Recruiting	Adrenal Function and Use of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) in Patients With Alopecia Areata Condition: Alopecia Areata Intervention: Drug: Triamcinolone Acetonide 10 mg/mL (Kenalog-10)

(Addison's Disease) Consider Celiac Disease in Autoimmune Disorder Patients

By: SHARON WORCESTER, Internal Medicine News Digital Network

DESTIN, FLA. – Consider screening for celiac disease in children with juvenile idiopathic arthritis, arthromyalgias, and myositis, advised Dr. Alexa B. Adams at the Congress of Clinical Rheumatology. 

Celiac disease has a strong association with numerous autoimmune disorders. Untreated celiac disease poses serious health consequences, such as short stature, failure to thrive, osteopenia/osteoporosis, and enteropathy-associated T-cell lymphoma. Early diagnosis and treatment could obviate or reduce the need for the more aggressive treatments that are typically prescribed for these associated autoimmune disorders, said Dr. Adams, a pediatric rheumatologist and pediatrician at Cornell University, New York. 

The identification and treatment of celiac disease in the setting of autoimmune disorders also appear to have the potential to alter the course of subsequent autoimmune disease, she said.

A link between celiac disease and juvenile idiopathic arthritis (JIA), for example, is well established. Several studies have demonstrated an increased prevalence of celiac disease among children with JIA, and cases of celiac disease in association with juvenile spondyloarthropathies and with pauciarticular, polyarticular, and psoriatic arthritis also have been reported. Furthermore, data show that a gluten-free diet can improve the musculoskeletal symptoms that are associated with celiac disease. 

The mechanisms for the association between JIA and celiac disease are unknown, but may be related to ongoing intestinal permeability in untreated celiac disease, Dr. Adams said, adding that she advocates screening for celiac disease in all JIA patients. 

She described a case involving a 6-year-old boy who presented with pain and swelling of the knee as well as morning stiffness. He had previously been treated for Lyme disease, and he had a 2-year history of headaches, behavioral problems, and poor growth, compared with his identical twin. 

Based on physical and laboratory examinations (serology was negative for celiac disease) and after the young patient was referred to pediatric infectious disease and neurology specialties where he underwent lumbar puncture and brain MRI, the treatment focused on possible central nervous system Lyme disease. Although his joint complaints were resolved, he had persistent headaches, poor growth, and worsening transaminitis. 

The boy tested negative for infectious and autoimmune hepatitis. An abdominal ultrasound showed fatty infiltration of the liver. Ultimately, the child was referred to a pediatric gastroenterologist. Work-up, including duodenal biopsy, showed findings that were consistent with celiac disease, and a gluten-free diet was initiated. 

"On a gluten-free diet, the child’s headaches resolved, he had no recurrence of joint pain, he was growing and gaining weight, and he had no further behavioral issues," Dr. Adams said.

An early diagnosis of celiac disease in a JIA patient and early initiation of a gluten-free diet can prevent unnecessary treatment with NSAIDs, disease-modifying antirheumatic drugs, and anti–tumor necrosis factor agents. The patent can also avoid unnecessary imaging and joint injections. 

Associations between celiac disease and adult rheumatoid arthritis/seronegative arthritides also exist, but are not as robust as that seen between celiac disease and JIA. 

The coexistence of adult RA and positive celiac antibodies – including EmA (endomysial antibodies) and gliadin IgA – has been well described, but an association with biopsy-proven celiac disease has not borne out, Dr. Adams said. 

The same is true in adult spondyloarthropathy. 

It is possible that there are age-related differences in gluten tolerance or in the pathogenesis of arthritis and/or gut permeability that can explain the age-related differences, but this remains unclear, she noted. 

As for celiac disease and myositis, the associations are well documented in both the pediatric rheumatology and pediatric gastroenterology literature, and also (although only more recently) in the adult literature. 

Interestingly, a high prevalence of the DQAI*0501 allele is found in both diseases, Dr. Adams noted. 

Because treatment of inflammatory myositis often requires significant use of glucocorticoids and sometimes additional immunosuppressive therapy, screening for celiac disease should be considered in myositis patients, she said, describing two cases involving young girls who were diagnosed with myositis and polymyositis, respectively. Both failed to respond adequately to prednisone/methotrexate, and both are doing well now on only a gluten-free diet after being diagnosed with celiac disease on biopsy. 

Screen for celiac disease in patients with vague musculoskeletal complaints who don’t respond to treatment, she said. These are the patients with whom "you just don’t know what to do," she said, adding that these are the patients who don’t clearly have arthritis, whose symptoms are out of proportion to findings on examination, whose symptoms impact their participation in sports or other activities, and who fail to respond well to a number of treatments. Often these patients will be diagnosed with fibromyalgia – a diagnosis that is unusual in young patients and should raise concern about possible other causes, she added.

In these cases, maintain a high index of suspicion for celiac disease, she said, describing the case of a 16-year-old girl who had given up sports because of a 2-year history of increasing pain in the calves, forearms, Achilles tendon, heels, and back. The skin on her thighs and calves was sensitive to touch, but she had no GI symptoms and had normal growth. 

Massage, chiropractic manipulation, acupuncture, electrical stimulation, and saline injection in her calf all failed to alleviate her symptoms. The child was diagnosed with fibromyalgia and treated with gabapentin, an over-the-counter NSAID, as well as intensive physical therapy.

After a gastroenterology referral, she was diagnosed with celiac disease based on biopsy findings, and was started on a gluten-free diet. At 5 months, she was symptom free and was once again active in sports activities. 

Given the consistent findings associating celiac disease with certain autoimmune disorders, and the safety and effectiveness of the gluten-free diet that is used to treat celiac disease, screening deserves consideration in these patients, she concluded. 

An association between celiac disease and systemic autoimmune disease has been reported, but is less established than the association between celiac disease and nonsystemic autoimmune disorders, Dr. Adams said. 

Reports of a link between celiac disease and systemic lupus erythematosus (SLE), for example, are limited to case reports, and at this point should be "taken with a grain of salt," she said. 

However, it does appear that in children the celiac disease diagnosis typically precedes the SLE diagnosis, whereas the converse is true in adults. 

Also, reports of SLE following celiac disease despite histologic normalization of the celiac disease on biopsy suggest that the treatment of celiac disease via a gluten-free diet does not modify the disease course in SLE, as it appears to do in cases of arthritis and myositis (J. Clin. Gastroenterol. 2008;42:252-5), Dr. Adams said. 

There does, however, appear to be a fairly strong association between celiac disease and Sjögren’s syndrome. 

A 2003 report said Sjögren’s syndrome is present in up to 15% of patients with biopsy-proven celiac disease, and demonstrated that anti-tTG (tissue transglutaminase, a marker for celiac disease) is more prevalent in Sjögren’s syndrome than in other systemic rheumatic diseases (J. Rheumatol. 2003;30:2613-9). 

Systemic sclerosis and morphia have also been reported in association with celiac disease, Dr. Adams said. 

The strongest associations between celiac disease and systemic autoimmune disease are with adult idiopathic diabetes mellitus, autoimmune thyroid disease, Addison’s disease, and polyendocrinopathies, she added. 

More data are needed to define the prevalence of celiac disease in various subtypes of systemic autoimmune disease, she concluded. 

Dr. Adams serves as a speaker for Abbott Pharmaceuticals. She had no other relevant disclosures.

From http://www.internalmedicinenews.com/news/gastroenterology/single-article/consider-celiac-disease-in-autoimmune-disorder-patients/9e1f371327.html

Overactive adrenal glands (Cushing's syndrome)

Overview

If your child’s adrenal glands produce excessive amounts of certain hormones, they are said to be overactive. The symptoms (and treatment) of overactive adrenal glands depends on which hormone is being overproduced.
Some of the most commonly overproduced hormones are:

• Androgenic steroids (also known as androgen hormones)
  • Testosterone is one of the most well-known androgen hormones. Excessive production of this or other androgen hormones can lead to exaggerated male characteristics in both men and women (like excess hair on the face and body, baldness, acne, a deeper voice and increased muscle mass).
  • If a female fetus is exposed to high levels of androgens early during a mother’s pregnancy, her genitals may develop abnormally. Young boys who experience high levels of androgen levels may grow faster, but their bones may also mature faster and stop growing too soon.
• Aldosterone hormone
  • Overproduction of aldosterone hormone can lead to high blood pressure and to symptoms associated with low levels of potassium (like weakness, muscle aches, spasms and sometimes paralysis).
• Corticosteroids
  • An overproduction of corticosteroids leads to the condition known as Cushing’s syndrome. Rare in children, it’s more commonly seen in adults.
  
  

What causes Cushing’s syndrome?
Cushing’s syndrome—the overproduction of corticosteroids—may be caused by an overproduction of cortisol (the hormone that controls the adrenal gland) by the pituitary gland. Other causes of Cushing’s syndrome include:

• certain lung cancers and other tumors outside the pituitary gland
• benign (non-cancerous) or cancerous tumors on the adrenal gland(s)

What are the symptoms of Cushing’s syndrome?
Children and adolescents with Cushing's syndrome experience weight gain, growth retardation and hypertension (high blood pressure). Other symptoms may include:

• upper body obesity
• round or moon-shaped face
• increased fat around neck
• thinning arms and legs
• fragile and thin skin
• darkened pigmentation of the skin
• acne
• bruising
• stretch marks on abdomen, thighs, buttocks, arms, and breasts
• bone and muscle weakness
• severe fatigue
• high blood sugar
• irritability and anxiety
• excessive hair growth in females
• irregular or stopped menstrual cycles in females
• reduced sex drive and fertility in males

How do doctors diagnose an overactive adrenal glands?
In addition to a complete medical history and physical examination, your child’s doctor will order specific blood and/or urine tests to measure hormone levels.

How can doctors tell if my child has Cushing’s syndrome?
In addition to a complete medical history and physical examination, your child’s doctor may request some or all of the following procedures:

• x-ray - a diagnostic test which uses invisible electromagnetic energy beams to produce images of internal tissues, bones and organs onto film
• 24-hour urinary test (urine is collected over a 24-hour period to measure corticosteroid hormones)
• computerized tomography scan (Also called a CT or CAT scan) - a diagnostic imaging procedure that uses a combination of x-rays and computer technology to produce cross-sectional images (often called slices), both horizontally and vertically, of the body
• magnetic resonance imaging (MRI) - a diagnostic procedure that uses a combination of large magnets, radiofrequencies and a computer to produce detailed images of organs and structures within the body
• dexamethasone suppression test (to differentiate whether the excess production of corticotropins originates from the pituitary gland or tumors elsewhere)
• corticotropin-releasing hormone (CRH) stimulation test (to differentiate whether the cause is a pituitary tumor or an adrenal tumor)

How are overactive adrenal glands/Cushing’s syndrome treated?
Treatment for overactive adrenal glands may include surgical removal of growths on the adrenal gland(s) or the adrenal gland(s) itself. Your doctor may also prescribe medications that block the excessive production of certain hormones.

From https://web1.tch.harvard.edu/az/Site1405/mainpageS1405P0.html

Adrenal venous sampling is crucial before an adrenalectomy whatever the adrenal-nodule size on computed tomography

Journal of Hypertension:

June 2011 - Volume 29 - Issue 6 - p 1196–1202

doi: 10.1097/HJH.0b013e32834666af

Original papers: Aldosterone

Adrenal venous sampling is crucial before an adrenalectomy whatever the adrenal-nodule size on computed tomography

Sarlon-Bartoli, Gabriellea; Michel, Nicolasa; Taieb, Davidb; Mancini, Julienc; Gonthier, Camillea; Silhol, Françoisa; Muller, Cyrild; Bartoli, Jean-Micheld; Sebag, Frédérice; Henry, Jean-Françoise; Deharo, Jean-Claudea; Vaisse, Bernarda

Abstract

Objective: To assess the additional value of adrenal venous sampling (AVS) to diagnose primary aldosteronism sub-types in patients who have a unilateral nodule detected by computed tomography (CT scan) and who should undergo an adrenalectomy.

Methods: A retrospective study to assess consecutive patients with primary aldosteronism undergoing an adrenal CT scan and AVS. Criterion for selective cannulation was an equal or higher cortisol level in the adrenal vein compared to the inferior vena cava. An adrenal-vein aldosterone-to-cortisol ratio of at least two times higher than the other side defined lateralization of aldosterone production.

Results: Sixty-seven patients (mean age 52 years, 39 men) underwent a CT scan accccand AVS. In nine patients (13%), cannulation of the right adrenal vein led to a technical failure. Both procedures led to diagnosis of 29 patients with adenoma-producing aldosterone (APA; 50%), 23 bilateral adrenal hyperplasias (40%), and six unilateral adrenal hyperplasias (10%). Of the 45 patients with a nodule detected by CT, subsequent AVS showed bilateral secretion in 16 patients (36%). Compared to the strategy of coupling CT scans with AVS to diagnosis APA, a CT scan alone had an accuracy of 72.4% (P < 0.001). Among patients with a macronodule detected by CT, 13 (37%) had bilateral secretion as assessed by AVS. The patients with a macronodule detected by CT alone had the same risk of a discrepancy as those with a small nodule (P = 0.99).

Conclusion: AVS is essential to diagnose the unilateral hypersecretion of aldosterone, even in patients in whom a unilateral macronodule is detected by CT, to avoid unnecessary surgery.

From http://journals.lww.com/jhypertension/Abstract/2011/06000/Adrenal_venous_sampling_is_crucial_before_an.24.aspx

NIH Adrenal Clinical Trials Updated 5/5/2011

Rank	Status	Study
1	Completed	Cardiovascular Risk in Patients With Non-Functional Adrenal Incidentaloma Condition: Adrenal Cortex Neoplasms Intervention:
2	Completed Has Results	Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation Condition: Adrenal Gland Neoplasms Intervention: Procedure: Radiofrequency ablation
3	Completed	Adrenal Scans With Radioiodine-Labeled Norcholesterol (NP-59) Conditions: Adrenal Gland Neoplasms;   Adrenal Malignancies;   Abnormal Hormonal Secretions;   Electrolytes Abnormalities Intervention: Other: Imaging, Adrenal acans
4	Recruiting	Trial of Vasopressin and Epinephrine to Epinephrine Only for In-Hospital Pediatric Cardiopulmonary Resuscitation Conditions: Cardiopulmonary Arrest;   Cardiac Arrest Interventions: Drug: Vasopressin;   Drug: Epinephrine
5	Completed	Adrenal Suppression and Adrenal Recovery Induced by Megestrol Acetate Condition: Adrenal Function Intervention: Drug: megestrol acetate
6	Recruiting	Test Predicting Adrenal Insufficiency in Volunteers Under Prednisone Treatment Condition: Adrenal Gland Hypofunction Interventions: Procedure: adrenal insufficiency testing;   Drug: prednisone
7	Recruiting	The Bupivacaine Dose Sparing Effect of Intrathecal Epinephrine Condition: Spinal Anesthesia Interventions: Drug: Placebo;   Drug: epinephrine 25;   Drug: Epinephrine 50;   Drug: epinephrine 100;   Drug: Epi 200
8	Recruiting	SPARTACUS: Subtyping Primary Aldosteronism: a Randomized Trial Comparing Adrenal Vein Sampling and Computed Tomography Scan. Condition: Hyperaldosteronism Intervention: Other: Ct-scan or adrenal vein sampling
9	Completed	Make up for the Epinephrine Autoinjector Condition: Anaphylaxis Intervention: Device: Epinephrine autoinjector
10	Completed	Epinephrine Inhalation Aerosol USP, a HFA-MDI Study for Assessment of Pharmacokinetics Conditions: Asthma;   Bronchospasm;   Wheezing;   Shortness of Breath Interventions: Drug: Epinephrine Inhalation Aerosol, HFA;   Drug: Epinephrine Inhalation Aerosol
11	Completed	Once-Daily Oral Modified-Release Hydrocortisone in Patients With Adrenal Insufficiency Condition: Adrenal Insufficiency Interventions: Drug: hydrocortisone (modified release), oral tablet 20 and 5 mg;   Drug: Hydrocortisone, oral tablet, 10 mg
12	Completed	Pharmacokinetics (PK) Study of Epinephrine Inhalation Aerosol in Healthy Volunteers Condition: Asthma Intervention: Drug: epinephrine inhalation aerosol
13	Completed	ED50 and ED95 of Intrathecal Bupivacaine With or Without Epinephrine for Total Knee Replacement Arthroplasty Conditions: Spinal Anesthesia;   Total Knee Replacement Arthroplasty Interventions: Drug: intrathecal bupivacaine 6 mg with 100 mcg of epinephrine;   Drug: intrathecal bupivacaine 7 mg with 100 mcg of epinephrine;   Drug: intrathecal bupivacaine 8 mg with 100 mcg of epinephrine;   Drug: intrathecal bupivacaine 9 mg with 100 mcg of epinephrine;   Drug: intrathecal bupivacaine 10 mg with 100 mcg of epinephrine;   Drug: intrathecal bupivacaine 11 mg with epinephrine 100 mcg;   Drug: intrathecal bupivacaine 6 mg with 200 mcg of epinephrine;   Drug: intrathecal bupivacaine 7 mg with 200 mcg of epinephrine;   Drug: intrathecal bupivacaine 8 mg with 200 mcg of epinephrine;   Drug: intrathecal bupivacaine 9 mg with 200 mcg of epinephrine;   Drug: intrathecal bupivacaine 10 mg with 200 mcg of epinephrine;   Drug: intrathecal bupivacaine 11 mg with 200 mcg of epinephrine
14	Active, not recruiting	Study of UK Adults With Congenital Adrenal Hyperplasia. Condition: Congenital Adrenal Hyperplasia Intervention:
15	Not yet recruiting	Intranasal Injection Versus Topical Administration of Epinephrin During Endoscopic Sinus Surgery Conditions: Hypertension;   Hypotension;   Tachycardia;   Bradycardia;   Arrhythmia Interventions: Drug: Epinephrin (Intranasal injection);   Drug: Epinephrin (Topical administration)
16	Recruiting	Adrenal Insufficiency in Septic Shock Conditions: Septic Shock;   Acute Adrenal Insufficiency Intervention: Drug: Corticosteroid
17	Recruiting	Performance of 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in the Diagnosis of Indeterminate Adrenal Tumors on Conventional Imaging: A French Prospective Multicentric Study Condition: Adrenal Gland Neoplasms Intervention: Other: FDG-PET scan
18	Unknown †	Prospective Study on the Incidence of Adrenal Crisis in Patients With Chronic Adrenal Insufficiency Condition: Adrenal Insufficiency Intervention:
19	Completed	Dose Response Relationship for Single Doses of Corticotropin Releasing Hormone (CRH) in Normal Volunteers and in Patients With Adrenal Insufficiency Conditions: Adrenal Gland Hyperfunction;   Adrenal Gland Hypofunction;   Cushing's Syndrome;   Healthy Intervention: Drug: Ovine Corticotropin-Releasing Hormone (oCRH)
20	Recruiting	Adrenal Function in Critical Illness Condition: Adrenal Insufficiency Intervention:

Rank	Status	Study
21	Recruiting	Study of Adrenal Gland Tumors Condition: Adrenal Gland Neoplasm Intervention:
22	Recruiting	The Effects of Epinephrine in Endotoxemia in Normal Volunteers Condition: Immune System Interventions: Biological: Endotoxin, Lipopolysaccharide, LPS;   Biological: Endotoxin, Lipopolysaccharide, LPS /Epinephrine
23	Unknown †	Does Topical Steroid Treatment Impair the Adrenal Function? Conditions: Hypothalamus-Pituitary-Adrenal Axis Assessement;   Topical Steroid Therapy in Chronic Skin Diseases Intervention:
24	Recruiting	Combination Local Anesthetics Condition: Perioperative Pain Interventions: Drug: 1% Lidocaine with Epinephrine;   Drug: 0.25% Bupivacaine with epinephrine;   Drug: 1% Lidocaine + 0.25% Bupivacaine with Epinephrine;   Drug: 2% Lidocaine + 0.5% Bupivacaine with epinephrine
25	Recruiting	Study Comparing Peri-articular Injection of Bupivacaine With and Without Epinephrine Condition: Osteoarthritis Interventions: Procedure: Peri-articular injection of marcaine/epinephrine;   Procedure: Peri-articular injection of marcaine alone
26	Not yet recruiting	Gluing Lacerations Utilizing Epinephrine Condition: Lacerations Intervention: Drug: LET - Lidocaine Epinephrine Tetracaine
27	Recruiting	Use of Local Analgesia With Epinephrine During Total Hip Arthroplasty (THA) Condition: Arthroplasty, Replacement, Hip Intervention: Drug: ropivacaine, physical serum and adrenalin
28	Recruiting	Relative Adrenal Insufficiency in Preterm Very Low Birth Weight Infants With Shock Condition: Adrenal Insufficiency Intervention:
29	Unknown †	Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Hydrocortisone on Renal and Haemodynamic Function Condition: Cirrhosis With Ascites Interventions: Drug: hydrocortisone;   Drug: dextrose solution 5%
30	Recruiting	Bronchiolitis, Optimal Treatment in Infants and Prognosis Condition: Bronchiolitis Interventions: Drug: Racemic adrenaline;   Drug: Isotonic saline
31	Recruiting	RAD001 in Pheochromocytoma or Nonfunctioning Carcinoid Conditions: Pheochromocytoma;   Extra-Adrenal Paraganglioma;   Non-functioning Carcinoid Intervention: Drug: RAD001
32	Not yet recruiting	Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q4 Condition: Type 1 Diabetes Intervention: Drug: epinephrine
33	Recruiting	Effect of Epinephrine/ Phenylephrine for Preventing the Postreperfusion Syndrome During Reperfusion in Liver Transplantation Condition: Hypotension After Reperfusion in Liver Transplantation Interventions: Drug: phenylephrine;   Drug: epinephrine;   Drug: placebo control
34	Recruiting	Safety Study Evaluating the Adrenal Suppression Potential of Product 0405 in Pediatric Subjects With Atopic Dermatitis Condition: Atopic Dermatitis Intervention: Drug: Product 0405
35	Recruiting	Merits of Continuous Paravertebral Block in the Management of Renal/Adrenal Surgery by Laparotomy Condition: Patient Scheduled for Renal and/or Adrenal Surgery Intervention: Procedure: Continuous Paravertebral block
36	Not yet recruiting	Adrenalectomy Versus Follow-up in Patients With Subclinical Cushings Syndrome Condition: Adrenal Tumour With Mild Hypercortisolism Intervention: Procedure: Adrenalectomy
37	Recruiting	Role of the Protein Osteoprotegerin in the Bone Health of Women With Congenital Adrenal Hyperplasia Condition: Adrenal Hyperplasia, Congenital Intervention:
38	Recruiting	Gene Polymorphisms Influencing Steroid Synthesis and Action Conditions: Disorders of Sex Development;   Congenital Adrenal Hyperplasia;   Congenital Adrenal Hypoplasia;   Adrenal Insufficiency;   Mineralocorticoid Deficiency;   Intersex Intervention:
39	Recruiting	Adrenal Function and Use of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) in Patients With Alopecia Areata Condition: Alopecia Areata Intervention: Drug: Triamcinolone Acetonide 10 mg/mL (Kenalog-10)
40	Recruiting	Assessment of the Efficacy of Nebulised 3% Hypertonic Saline Among Infants Aged 6 Weeks- 24 Months With Bronchiolitis Condition: Bronchiolitis Interventions: Drug: L-Epinephrine and 0.9% Normal Saline;   Drug: L-Epinephrine and 3% Hypertonic Saline

Congenital adrenal hyperplasia (CAH)

PerkinElmer's Neonatal17 a-OH-Progesterone (17OHP) assay for its DELFIA®, AutoDELFIA® and GSP® platforms platforms provides the highest standards of reliability and safety in screening for congenital adrenal hyperplasia (CAH). It is globally the most widely used assay for 1st tier CAH screening, and in 2008 theproduct was used in 47 countries.

No extraction step needed

The assay is a straightforward dried blood spot assay.  No extraction step is needed, which means savings in both total assay time and materials.

DELFIA®-technology stands for quality

The unique fluorescent properties of lanthanide chelatesare the basis for high sensitivity and low assay variation, and these features, in turn, stand for reliable and accurate 17a-OH-Progesterone measurement with low bias.

Early diagnosis for early disease/Intervention

Congenital adrenal hyperplasia is a genetic disorder affecting 1:10,000 to 1:15,000 newborns worldwide and the most severe form of the disease can lead to a life-threatening condition during the first weeks of life.  The disease is caused by enzyme defects in the steroid biosynthesis, the most frequent types being 21- and 11a-hydroxylase deficiency. In both of these the17a-OH-progesterone, a precursor for cortisol, is increased which makes its determination a useful screening method for 95% of all of the CAH cases.

PerkinElmer's Neonatal 17OHP assay is intended for the quantitative determination of 17a-OH-progesterone indried blood spot specimens as an aid in screening newborns for CAH.

From http://www.perkinelmer.com/Catalog/Category/ID/Congenital%20adrenal%20hyperplasia%20CAH

More on last article: Additional autoimmune disease found in one-third of patients with type 1 diabetes

At diagnosis of type 1 diabetes, approximately 33% of patients are positive for at least one additional organ-specific autoantibody, according to new data.

Researchers at the Barbara Davis Center for Childhood Diabetes assessed 491 children diagnosed with type 1 diabetes from 2004 to 2009 for other autoimmune conditions. They measured thyroid peroxidase autoantibodies (TPOAb) to screen for autoimmune thyroid disease, tissue transglutaminase autoantibodies (TTGAb) for celiac disease and 21-hydroxylase autoantibodies (21OHAb) for Addison’s disease.

“We sought to define the prevalence of nonislet, organ-specific autoantibodies at the diagnosis of type 1 diabetes and to determine the prevalence of comorbid autoimmune diseases,” the researchers wrote.

Of the 491 children, 82.7% were white and 53.4% were boys. At the time of diagnosis with type 1 diabetes, mean age was 9.6 years and the average HbA1c level was 11.6%.

Measurements of TPOAb, TTGAb and 21OHAb were collected within 16 days, on average, and patients were diagnosed with autoimmune thyroid disease, celiac disease or Addison’s disease within 45 days.

Overall, 32.6% of the children had at least one nonislet, organ-specific autoantibody. Of these, 18.6% were diagnosed with additional autoimmune disease. Results revealed that 24.8% were positive for TPOAb, of whom 12.3% had autoimmune thyroid disease. Of the 11.6% with TTGAb, 24.6% had celiac disease. Just 1% of children had 21OHAb, and the researchers found only one case of Addison’s disease.

“Ongoing follow-up of this cohort will be important to determine the natural history of organ-specific autoimmunity in patients with type 1 diabetes,” the researchers wrote. “Key questions remain, including the incidence of autoantibodies over time, the evolution from positive antibodies to disease, the genetic influences on autoimmunity and disease, and patient characteristics that may influence antibody or disease development.”

For more information:

• Triolo TM. Diabetes Care. 2011;doi:10.2337/dc10-1756.

Disclosure: The researchers report no relevant financial disclosures.
From http://www.endocrinetoday.com/view.aspx?rid=83019

Type 1 Diabetes, Celiac or Addison’s?

After noticing a growing trend in children diagnosed with Type 1 Diabetes, doctors and medical researchers have announced a new study measuring the correlation between this autoimmune disorder as well as three others. Addison’s disease, celiac disease, and autoimmune thyroid disease often have antibodies present in children at the same time that they are diagnosed with Type 1 Diabetes.


It has recently been reported that fifteen to thirty percent of people with Type 1 diabetes have also been diagnosed, and about 4 to 9 percent have been diagnosed with celiac disease. Addison’s disease is at the bottom of the list with less than one percent being diagnosed. Children who have been confirmed to have diabetes should be tested yearly for an autoimmune thyroid disease, and for celiac disease if other symptoms become apparent. There is no real screening schedule for Addison’s disease.

From http://www.adi-news.com/type-1-diabetes-celiac-or-addisons/211165/

Gastric inhibitory polypeptide-dependent cortisol hypersecretion

André Lacroix, M.D., Edouard Bolté, M.D., Johanne Tremblay, Ph.D., John Dupré, M.D., Pierre Poitras, M.D., Hélène Fournier, M.D., Jean Garon, M.D., Dominique Garrel, M.D., Francis Bayard, M.D., Ph.D., Raymond Taillefer, M.D., Richard J. Flanagan, Ph.D., and Pavel Hamet, M.D., Ph.D.

N Engl J Med 1992; 327:974-980October 1, 1992

Abstract

Background.

Corticotropin-independent nodular adrenal hyperplasia is a rare cause of Cushing's syndrome, and the factors responsible for the adrenal hyperplasia are not known.

Full Text of Background....

Methods.

We studied a 48-year-old woman with Cushing's syndrome, nodular adrenal hyperplasia, and undetectable plasma corticotropin concentrations in whom food stimulated cortisol secretion.

Full Text of Methods....

Results.

Cortisol secretion had an inverse diurnal rhythm in this patient, with low-to-normal fasting plasma cortisol concentrations and elevated postprandial cortisol concentrations that could not be suppressed with dexamethasone. The cortisol concentrations increased in response to oral glucose (4-fold increase) and a lipid-rich meal (4.8-fold increase) or a protein-rich meal (2.6-fold increase), but not intravenous glucose. The infusion of somatostatin blunted the plasma cortisol response to oral glucose. Intravenous infusion of gastric inhibitory polypeptide (GIP) for one hour increased the plasma cortisol concentration in the patient but not in four normal subjects. Fasting plasma GIP concentrations in the patient were similar to those in the normal subjects; feeding the patient test meals induced increases in plasma GIP concentrations that paralleled those in plasma cortisol concentrations. Cell suspensions of adrenal tissue from the patient produced more cortisol when stimulated by GIP than when stimulated by corticotropin. In contrast, adrenal cells from normal adults and fetuses or patients with cortisol-producing or aldosterone-producing adenomas responded to corticotropin but not to GIP.

Full Text of Results....

Conclusions.

Nodular adrenal hyperplasia and Cushing's syndrome may be food-dependent as a result of abnormal responsiveness of adrenal cells to physiologic secretion of GIP. "Illicit" (ectopic) expression of GIP receptors on adrenal cells presumably underlies this disorder. (N Engl J Med 1992;327:974–80.)

Full Text of Conclusions....

Read the Full Article...

Media in This Article

Figure 1Plasma Cortisol Concentrations in a Patient with Food-Induced Cushing's Syndrome during Fasting and after Eating.

Figure 2Plasma Cortisol and GIP Responses to Oral Glucose Administration (○), Intravenous Glucose Administration (●), and Protein-Rich (□) and Lipid-Rich () Meals in a Patient with Food-Induced

Presentation of Primary Adrenal Insufficiency in Childhood

Susan Hsieh and Perrin C. White

Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas 75390

Address all correspondence and requests for reprints to: Perrin C. White, M.D., University of Texas Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, Texas 75390-9063. E-mail: perrin.white@utsouthwestern.edu

Context: Primary adrenal insufficiency is usually diagnosed in infancy or adulthood, and cases presenting in childhood have not been systematically reviewed.

Objective: Our objective was to determine etiologies, signs, and symptoms of primary adrenal insufficiency presenting in childhood.

Design and Setting: We conducted a retrospective chart review at a tertiary-care pediatric hospital.

Patients: Patients were children with corticoadrenal insufficiency, glucocorticoid deficiency, or mineralocorticoid deficiency.

Results: Seventy-seven cases were identified in 1999–2010. Thirty-five had congenital adrenal hyperplasia (CAH) and were not reviewed further. Forty-two patients (20 diagnosed at our institution) had primary adrenal insufficiency. These had etiologies as follows: autoimmune (18), autoimmune polyendocrinopathy syndrome (an additional five), ACTH resistance (four), adrenoleukodystrophy (three), adrenal hypoplasia congenita (two), adrenal hemorrhage (two), IMAGe syndrome (one), and idiopathic (two). Of 20 patients diagnosed at our institution, two were being monitored when adrenal insufficiency developed and were not included in the analysis of presenting signs and symptoms: 13 of 18 patients were hypotensive; 12 of 18 had documented hyperpigmentation. Hyponatremia (<135 mEq/liter) occurred in 16 of 18. However, hyperkalemia (>5.0 mEq/liter) was noted in only nine. Hypoglycemia and ketosis were documented in four of 15 and four of six patients in whom it was sought, respectively. Fifteen patients underwent cosyntropin stimulation testing with median baseline and stimulated cortisol of 1.1 and 1.2 µg/dl, respectively. ACTH and renin were markedly elevated in all patients.

Conclusions: Hyperkalemia is not a consistent presenting sign of primary adrenal insufficiency in childhood, and its absence cannot rule out this condition. A combination of chronic or subacute clinical symptoms, hypotension, and hyponatremia should raise suspicion of adrenal insufficiency.

From http://jcem.endojournals.org/cgi/content/abstract/jc.2011-0015v1