The Hypothalamic-Pituitary-Adrenal (HPA) Axis as an Effector System in Weight Regulation
Information source: Oregon Health and Science University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity; Addison's Disease
Intervention: Hydrocortisone (Drug); Isocaloric Diet (Dietary Supplement)
Phase: N/A
Status: Completed
Sponsored by: Oregon Health and Science University
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.
Clinical Details
Official title: Cortisol, Central Obesity, and Insulin Resistance: Long Term Studies in Addison's Patients
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Amounts of intra-abdominal fat and total fat at the end of the treatment period for each cortisol dose.
Secondary outcome: Fasting Lipid levels, fat mass by DEXA, post-heparin lipase activity, insulin sensitivity, and fat biopsy
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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).
Locations and Contacts
Oregon Health & Science University, Portland, Oregon 97239, United States
Additional Information
Starting date: August 2000
Last updated: June 4, 2008
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