NIH Clinical Research Studies

Protocol Number: 01-CH-0096

Active Accrual, Protocols Recruiting New Patients

Title:
Catecholamine Reserve and Exercise Tolerance in Subjects with Congenital Adrenal Hyperplasia and in Healthy Controls
Number:
01-CH-0096
Summary:
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.

Sponsoring Institute:
National Institute of Child Health and Human Development (NICHD)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None

Eligibility Criteria:
INCLUSION CRITERIA:

Age: 10-40 years.

CAH patients on conventional therapy (glucocorticoids, mineralocorticoids) in good clinical management as defined by the following criteria:

a) 17-OH-progesterone level between 100 and 1500 ng/dL;

b) Plasma renin activity normal;

c) Growth rate within 2 SD for age (children);

d) No new signs or symptoms of virilization (clitoral growth, voice deepening) for females.

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.

Special Instructions: Currently Not Provided
Keywords:
CAH
Catecholamines
Adrenal Medulla
Endocrine
Recruitment Keywords:
Congenital Adrenal Hyperplasia
Exercise
Healthy Volunteer
Conditions:
Congenital Adrenal Hyperplasia
Healthy
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:
Triggering of sudden death from cardiac causes by vigorous exertion

Psycholphysical bases of perceived exertion

Stress hormones: their interaction and regulation

Active Accrual, Protocols Recruiting New Patients

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