Clinical Trial: The Hypothalamic-Pituitary-Adrenal (HPA) Axis as an Effector System in Weight Regulation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Cortisol, Central Obesity, and Insulin Resistance: Long Term Studies in Addison's Patients

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Oregon Health and Science University

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Fasting Lipid levels, fat mass by DEXA, post-heparin lipase activity, insulin sensitivity, and fat biopsy [ Time Frame: After 4-months on each dose ]

Original Secondary Outcome: Same as current

Information By: Oregon Health and Science University

Dates:
Date Received: May 30, 2008
Date Started: August 2000
Date Completion:
Last Updated: June 4, 2008
Last Verified: June 2008