An observational study in Congenital Adrenal Hyperplasia and Healthy, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Completed at 1 site in United States. Open to participants aged 9 Years to 40 Years. Per ClinicalTrials.gov, last updated 2017-07-02.
Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Observational
Among 50 studies in Adrenal Hyperplasia, Congenital with a site in United States — 10 open to participants now, 14 under way, 4 of them phase 3. Adrenal Hyperplasia, Congenital · United States.
Among the 50 studies in Adrenal Hyperplasia, Congenital with a site in United States, this one is the 8th largest by enrollment of the 11 observational ones, is the only one that started in 2001, is one of 11 observational ones, and was the 3rd registered.
101 studies on the registry are indexed under Adrenal Hyperplasia, Congenital; 28 are open to participants now.
This study's enrollment of 61 is close to the median of 61 across 44 observational studies indexed under Adrenal Hyperplasia, Congenital.
Browse Adrenal Hyperplasia, Congenital studies →10 of the 50 studies in Adrenal Hyperplasia, Congenital with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 20 Adrenal Hyperplasia, Congenital studies recruiting now, 10 (50%) set no upper age limit and 9 (45%) stop at 75 or younger; 7 take children under 18; 0 take healthy volunteers.
This study: 9 Years to 40 Years · all sexes · no healthy volunteers.
The full table on the hub →50 studies; the count open now beside each. This study's row is marked.
First in 1995; this study’s year is marked. 1 started in 2001.
Median enrollment 22 across the 38 interventional studies, 65 across the 11 observational. Of the 30 that completed or were terminated, 19 (63%) have results posted.
27 of 50 have an industry lead sponsor. The 10 most frequent:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is the lead sponsor of 422 studies on the registry; 24 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 11 (79%) have results posted.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) has 4 studies filed under Adrenal Hyperplasia, Congenital — fewer than ten, so there is no comparison to draw.
2 of the studies in Adrenal Hyperplasia, Congenital with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07144163Phase 3Crinetics Pharmaceuticals Inc.A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia | 2027-05 |
| NCT07104812Mayo ClinicImpact of 1 mg Osilodrostat Therapy on Mild Autonomous Cortisol Secretion (MACS) | 2027-01 |
Among the 50 studies in Adrenal Hyperplasia, Congenital with a site in United States, from their registry updates:
This study will examine and compare the effects of intense exercise on the release of catecholamines in patients with congenital adrenal hyperplasia (CAH) and in healthy persons. Catecholamines are hormones (adrenaline and noradrenaline) that are produced by the adrenal glands and released into the blood stream during stress, such as trauma, illness, intense exercise, or low blood sugar. The study will also assess exercise tolerance in patients with CAH, compared with healthy persons.
Patients with CAH between the ages of 10 and 40 years who are managing well on standard treatment (glucocorticoids, mineralocorticoids) may be eligible for this study. Healthy volunteers that match the enrolled patients in age, sex, race and body fat will be recruited as control subjects. All candidates will be screened with a medical history, physical examination and electrocardiogram (EKG). Body fat will be measured using an instrument called a Bod Pod. The body fat measurement has two parts: first, the subject sits quietly in a large egg-shaped capsule for about 2 to 3 minutes; then the subject breathes into a plastic tube for one minute, followed by three quick panting breaths. Women will have a urine pregnancy test; pregnant women cannot participate in the study.
Participants will undergo three exercise sessions on separate consecutive mornings after fasting overnight. Before each test, patients (not healthy volunteers) will take either an additional morning dose of hydrocortisone or a placebo (a lookalike pill with no active ingredient). Before each test a thin catheter (plastic tube) will be placed into an arm vein through a needle. A numbing cream can be applied to make the needle stick hurt less. Blood will be drawn through this intravenous (IV) line before, during and after the exercise tests. The first test is a maximal exercise test to determine the individual's maximum exercise fitness capacity. The second two and third tests are a standardized exercise tests. Before the two standardized tests, patients (not healthy volunteers) will take either an additional morning dose of hydrocortisone or a placebo (a lookalike pill with no active ingredient). All tests are done on a stationary bicycle.
Maximal Exercise Test - The subject pedals on a stationary bicycle for about 10 minutes. After a 3-minute warm-up, the workload is increased continuously until either the subject can no longer continue or the physician stops the test for medical reasons. During the exercise, heart rate and heart activity are monitored with an EKG, and the subject wears a nose clip and mouthpiece connected to a breathing tube to measure oxygen use. Blood is drawn before and during the test, totaling no more than 2 tablespoons.
Standardized Exercise Test - The subject pedals on a stationary bicycle for 20 minutes, while wearing the nose clip and mouthpiece to measure oxygen use. For the first 5 minutes, the subject pedals at a speed that elicits 50 percent of maximal effort (determined by the maximal exercise test); the next 10 minutes are at 70 percent of maximal effort; and the last 5 minutes are at 90 percent. Blood samples drawn before, during (at 15 and 20 minutes) and after exercise (at 30, 40 and 60 minutes) total less than 1/2 cup. Heart rate and heart activity are monitored during the test with an EKG, and temperature is measured before and at the end of the test.
Congenital adrenal hyperplasia (CAH) denotes a family of inherited disorders with defects in the cortisol biosynthesis. CAH has been traditionally considered a disease restricted to the adrenal cortex. However, recently observed abnormal adrenomedullary structures in three adrenalectomized patients with classic CAH, as well as low baseline urinary and plasma epinephrine levels in children with CAH suggest that this condition is associated with marked morphological and functional abnormalities of the adrenal medulla.
The adrenal medulla synthesizes and secretes catecholamines, mainly epinephrine. Catecholamines influence virtually all tissues. Yet, the clinical implications of epinephrine deficiency in humans are not clear.
Short-term intense exercise is a natural, quantifiable stimulus of the adrenal cortex and medulla as well as of the sympathetic nervous system. We would like to employ a standard cycle ergometer exercise protocol to study the adrenomedullary and systemic sympathetic function of patients with CAH. This protocol has been run by the Clinical Center Rehabilitation Medicine Department (RMD) for 10 years. No serious adverse effects have been observed or reported in adults and children with a healthy cardiovascular system.
The goal of this protocol is to evaluate adrenomedullary and systemic sympathetic function and exercise tolerance in patients with CAH and in appropriately matched healthy controls using the above standardized cycle ergometer test. Subjects with CAH will exercise with and without doubling their morning dose of hydrocortisone to evaluate whether impairments - if present - can be corrected by a "stress dose" of hydrocortisone. We hypothesize that subjects with CAH have a reduced epinephrine reserve and impaired exercise tolerance, which can at least partially, be corrected by an increase in exogenous hydrocortisone. We will also determine whether the systemic sympathetic nervous system compensates for the adrenomedullary deficiency as observed in states of acquired adrenal insufficiency. The results of this study will increase the understanding of the physiologic interactions between adrenal cortex and adrenal medulla.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age: 9-40 years.
CAH patients on conventional therapy (, mineralocorticoids) in good clinical management as defined by the following criteria:
Healthy volunteers will be matched for age, sex, race and body fat.
EXCLUSION CRITERIA:
Inability to understand or comply with instructions related to the study (as judged by investigator).
Chronic medical conditions other than congenital adrenal hyperplasia except mild conditions (e.g. allergic rhinitis, migraine headaches) will be excluded provided the subjects are not acutely ill and do not require medication for this condition during the study.
Acute medical conditions including intercurrent infection and fever in the preceding 7 days.
Positive pregnancy test.
CAH patients on flutamide.
Tylenol or other acetaminophen-containing medicines (e.g. over-the-counter cold medicines) within 5 days before each test period.
Caffeine, alcohol or strenuous exercise within 24 h before each test period.
Current smokers.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The record gives a start of Feb 2001 and a completion of May 2011. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.
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Adrenal Hyperplasia, Congenital →
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