NCT00688987

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Obesity
• Addison's Disease

Interventions

Type	Name	Description
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.
DIETARY_SUPPLEMENT	Isocaloric Diet	Subjects will eat an isocaloric diet for 4 weeks while taking hydrocortisone

Timeline

• Start date: 2000-08-01
• Primary completion: 2004-07-01
• Completion: 2004-08-01
• First posted: 2008-06-03
• Last updated: 2008-06-05

Locations

1 site across 1 country: United States