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

NCT ID: NCT00688987

Last Updated: 2008-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-08-31
• Study Completion Date: 2004-08-31

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Subjects with AI will be randomized to each of three doses of hydrocortisone for 4 months on each dose.

Group Type: ACTIVE_COMPARATOR

Hydrocortisone

Intervention Type: DRUG

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.

2

isocaloric diet

Group Type: ACTIVE_COMPARATOR

Isocaloric Diet

Intervention Type: DIETARY_SUPPLEMENT

Subjects will eat an isocaloric diet for 4 weeks while taking hydrocortisone

Interventions

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.

Intervention Type: DRUG

Isocaloric Diet

Subjects will eat an isocaloric diet for 4 weeks while taking hydrocortisone

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Weight stable diet

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

OHSU - The Center for the Study of Weight Regulation

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

OCTRI #711

Identifier Type: -

Identifier Source: secondary_id

eIRB 545

Identifier Type: -

Identifier Source: org_study_id