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

June 4, 2008 updated by: Oregon Health and Science University

Cortisol, Central Obesity, and Insulin Resistance: Long Term Studies in Addison's Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Subjects with AI will be randomized to each of three doses of hydrocortisone for 4 months on each dose.
Drug: 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.
Active Comparator: 2
isocaloric diet
Dietary supplement: Isocaloric Diet
Subjects will eat an isocaloric diet for 4 weeks while taking hydrocortisone
Other Names:
  • Weight stable diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
After 4 months on each dose

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2000

Primary Completion (Actual)

July 1, 2004

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

May 30, 2008

First Submitted That Met QC Criteria

May 30, 2008

First Posted (Estimate)

June 3, 2008

Study Record Updates

Last Update Posted (Estimate)

June 5, 2008

Last Update Submitted That Met QC Criteria

June 4, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • eIRB 545
  • OCTRI #711

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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