The Hypothalamic-Pituitary-Adrenal (HPA) Axis as an Effector System in Weight Regulation
This study has been completed.
Sponsor:
Oregon Health and Science University
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00688987
First received: May 30, 2008
Last updated: June 4, 2008
Last verified: June 2008
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Purpose
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 |
|---|---|
|
Obesity Addison's Disease |
Drug: Hydrocortisone Dietary Supplement: Isocaloric Diet |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Cortisol, Central Obesity, and Insulin Resistance: Long Term Studies in Addison's Patients |
Resource links provided by NLM:
Drug Information available for:
Hydrocortisone acetate
Hydrocortisone
Hydrocortisone sodium succinate
Hydrocortisone cypionate
Hydrocortisone butyrate
Hydrocortisone valerate
Hydrocortisone probutate
U.S. FDA Resources
Further study details as provided by Oregon Health and Science University:
Primary Outcome Measures:
- Amounts of intra-abdominal fat and total fat at the end of the treatment period for each cortisol dose. [ Time Frame: After 4 months on each dose ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Fasting Lipid levels, fat mass by DEXA, post-heparin lipase activity, insulin sensitivity, and fat biopsy [ Time Frame: After 4-months on each dose ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Active Comparator: 1
Subjects with AI will be randomized to each of three doses of hydrocortisone for 4 months on each dose.
|
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.
Other Name: hydrocortisone
|
|
Active Comparator: 2
isocaloric diet
|
Dietary Supplement: Isocaloric Diet
Subjects will eat an isocaloric diet for 4 weeks while taking hydrocortisone
Other Name: Weight stable diet
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects with complete adrenal failure as defined as spontaneous serum cortisol of levels less than 5 g/dl after 12 hours without glucocorticoid replacement and peak serum cortisol of < 5 g/dl 60 minutes after a 250 g ACTH stimulation test.
- Subjects who are at their usual weight (weight stable for at least 1 year)
- Subjects on stable replacement doses of any required hormone such as thyroid, sex hormones, mineralocorticoid replacement, growth hormone, and hydrocortisone for at least 6 months, and 4) have a normal body weight (BMI 19-27 kg/m2).
Exclusion Criteria:
- Possible confounders on body weight and insulin resistance
- Age less than 18 to exclude those who might be experiencing alterations in cortisol production or weight as a result of adolescent growth.
- Subjects who exercise > 30 minutes/day, 3 times a week.
- Smokers.
- Heavy alcohol drinkers (> 2 drinks/ day).
- Subjects with medical diagnosis including diabetes, heart disease, and cancer.
- Subjects with psychiatric illness (i.e., depression, psychosis, bipolar, schizophrenia; or are taking medications for these disorders).
Contacts and Locations More Information
No publications provided
| Responsible Party: | Jonathan Q. Purnell, OHSU - The Center for the Study of Weight Regulation |
| ClinicalTrials.gov Identifier: | NCT00688987 History of Changes |
| Other Study ID Numbers: | eIRB 545, OCTRI #711 |
| Study First Received: | May 30, 2008 |
| Last Updated: | June 4, 2008 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Addison Disease Obesity Adrenal Insufficiency Adrenal Gland Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Overnutrition Nutrition Disorders Overweight Body Weight |
Signs and Symptoms Cortisol succinate Hydrocortisone acetate Hydrocortisone 17-butyrate 21-propionate Hydrocortisone Hydrocortisone-17-butyrate Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Dermatologic Agents |
ClinicalTrials.gov processed this record on May 22, 2013