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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00688987
• Date of registration: 30/05/2008
• Prospective Registration: No
• Primary sponsor: Oregon Health and Science University
• Public title: The Hypothalamic-Pituitary-Adrenal (HPA) Axis as an Effector System in Weight Regulation
• Scientific title: Cortisol, Central Obesity, and Insulin Resistance: Long Term Studies in Addison's Patients
• Date of first enrolment: August 2000
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00688987
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

United States

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Addison's Disease

Obesity

Intervention(s)

Dietary Supplement: Isocaloric Diet

Drug: Hydrocortisone

Primary Outcome(s)

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]

Secondary Outcome(s)

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

Secondary ID(s)

OCTRI #711

eIRB 545

Source(s) of Monetary Support

Please refer to primary and secondary sponsors