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

• Status: Completed
• Trial end date: 2004-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University
• Treatments: Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate

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).