Status:
COMPLETED
The Hypothalamic-Pituitary-Adrenal (HPA) Axis as an Effector System in Weight Regulation
Lead Sponsor:
Oregon Health and Science University
Conditions:
Obesity
Addison's Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 tot...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2004
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00688987
Start Date
August 1 2000
End Date
August 1 2004
Last Update
June 5 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Oregon Health & Science University
Portland, Oregon, United States, 97239