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Study 13 of 27 for search of: | "Adrenoleukodystrophy" |
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Sponsored by: |
Oregon Health and Science University |
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Information provided by: | Oregon Health and Science University |
ClinicalTrials.gov Identifier: | NCT00688987 |
Replacing glucocorticoid in a dose dependent manner (including doses within the physiological range) to subjects with adrenal insufficiency will increase visceral fat accumulation independently of total fat mass.
Condition | Intervention |
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Obesity Addison's Disease |
Drug: Hydrocortisone Dietary Supplement: Isocaloric Diet |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Cortisol, Central Obesity, and Insulin Resistance: Long Term Studies in Addison's Patients |
Enrollment: | 24 |
Study Start Date: | August 2000 |
Study Completion Date: | August 2004 |
Primary Completion Date: | July 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Subjects with AI will be randomized to each of three doses of hydrocortisone for 4 months on each dose.
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Drug: Hydrocortisone
Subjects will receive in random order daily (split) dosing of hydrocortisone: a low dose of 15 mg (10 in AM, 5 in PM); a medium dose of 25 mg (15 in AM, 10 in PM) and high dose of 40 mg (30 in AM, 10 in PM) for 4 months.
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2: Active Comparator
isocaloric diet
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Dietary Supplement: Isocaloric Diet
Subjects will eat an isocaloric diet for 4 weeks while taking hydrocortisone
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To measure total fat mass by DEXA scan, central (visceral) fat accumulation, insulin sensitivity by FSIVGTT, lipid levels, and adipocyte gene expression in subjects with AI receiving increasing doses of hydrocortisone replacement (15 mg, 25 mg, and 40 mg per day in split doses) for 4-months at a time during ad-lib feeding.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | OHSU - The Center for the Study of Weight Regulation ( Jonathan Q. Purnell ) |
Study ID Numbers: | eIRB 545, OCTRI #711 |
Study First Received: | May 30, 2008 |
Last Updated: | June 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00688987 |
Health Authority: | United States: Institutional Review Board |
Addison's disease Hydrocortisone Adrenal Gland Diseases Demyelinating diseases Overweight Hypoadrenalism Brain Diseases Insulin Body Weight Signs and Symptoms Metabolism, Inborn Errors Heredodegenerative Disorders, Nervous System Peroxisomal Disorders Adrenoleukodystrophy Addison Disease |
Genetic Diseases, X-Linked Nutrition Disorders Brain Diseases, Metabolic, Inborn Epinephrine Neurobehavioral Manifestations X-linked adrenoleukodystrophy Obesity Adrenal Insufficiency Autoimmune Diseases Metabolic Diseases Cortisol succinate Demyelinating Diseases Endocrine System Diseases Central Nervous System Diseases Adrenal gland hypofunction |
Anti-Inflammatory Agents Immune System Diseases Therapeutic Uses Nervous System Diseases |
Mental Retardation, X-Linked Hereditary Central Nervous System Demyelinating Diseases Pharmacologic Actions |