The Hypothalamic-Pituitary-Adrenal (HPA) Axis as an Effector System in Weight Regulation
Cortisol, Central Obesity, and Insulin Resistance: Long Term Studies in Addison's Patients
2 other identifiers
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Aug 2000
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 30, 2008
CompletedFirst Posted
Study publicly available on registry
June 3, 2008
CompletedJune 5, 2008
June 1, 2008
3.9 years
May 30, 2008
June 4, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Amounts of intra-abdominal fat and total fat at the end of the treatment period for each cortisol dose.
After 4 months on each dose
Secondary Outcomes (1)
Fasting Lipid levels, fat mass by DEXA, post-heparin lipase activity, insulin sensitivity, and fat biopsy
After 4-months on each dose
Study Arms (2)
1
ACTIVE COMPARATORSubjects with AI will be randomized to each of three doses of hydrocortisone for 4 months on each dose.
2
ACTIVE COMPARATORisocaloric diet
Interventions
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.
Subjects will eat an isocaloric diet for 4 weeks while taking hydrocortisone
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oregon Health & Science University
Portland, Oregon, 97239, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 30, 2008
First Posted
June 3, 2008
Study Start
August 1, 2000
Primary Completion
July 1, 2004
Study Completion
August 1, 2004
Last Updated
June 5, 2008
Record last verified: 2008-06