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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00688987
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : June 5, 2008
Sponsor:
Information provided by:
Oregon Health and Science University

Tracking Information
First Submitted Date  ICMJE May 30, 2008
First Posted Date  ICMJE June 3, 2008
Last Update Posted Date June 5, 2008
Study Start Date  ICMJE August 2000
Actual Primary Completion Date July 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2008)
Fasting Lipid levels, fat mass by DEXA, post-heparin lipase activity, insulin sensitivity, and fat biopsy [ Time Frame: After 4-months on each dose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Hypothalamic-Pituitary-Adrenal (HPA) Axis as an Effector System in Weight Regulation
Official Title  ICMJE Cortisol, Central Obesity, and Insulin Resistance: Long Term Studies in Addison's Patients
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Addison's Disease
Intervention  ICMJE
  • 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.
  • Dietary Supplement: Isocaloric Diet
    Subjects will eat an isocaloric diet for 4 weeks while taking hydrocortisone
    Other Name: Weight stable diet
Study Arms  ICMJE
  • Active Comparator: 1
    Subjects with AI will be randomized to each of three doses of hydrocortisone for 4 months on each dose.
    Intervention: Drug: Hydrocortisone
  • Active Comparator: 2
    isocaloric diet
    Intervention: Dietary Supplement: Isocaloric Diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2008)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2004
Actual Primary Completion Date July 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00688987
Other Study ID Numbers  ICMJE eIRB 545
OCTRI #711
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jonathan Q. Purnell, OHSU - The Center for the Study of Weight Regulation
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Oregon Health and Science University
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP