The Hypothalamic-Pituitary-Adrenal (HPA) Axis as an Effector System in Weight Regulation
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ClinicalTrials.gov Identifier: NCT00688987 |
Recruitment Status :
Completed
First Posted : June 3, 2008
Last Update Posted : June 5, 2008
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Condition or disease | Intervention/treatment | Phase |
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Obesity Addison's Disease | Drug: Hydrocortisone Dietary Supplement: Isocaloric Diet | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | Cortisol, Central Obesity, and Insulin Resistance: Long Term Studies in Addison's Patients |
Study Start Date : | August 2000 |
Actual Primary Completion Date : | July 2004 |
Actual Study Completion Date : | August 2004 |

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.
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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
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Dietary Supplement: Isocaloric Diet
Subjects will eat an isocaloric diet for 4 weeks while taking hydrocortisone
Other Name: Weight stable diet |
- 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 ]
- Fasting Lipid levels, fat mass by DEXA, post-heparin lipase activity, insulin sensitivity, and fat biopsy [ Time Frame: After 4-months on each dose ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688987
United States, Oregon | |
Oregon Health & Science University | |
Portland, Oregon, United States, 97239 |
Responsible Party: | Jonathan Q. Purnell, OHSU - The Center for the Study of Weight Regulation |
ClinicalTrials.gov Identifier: | NCT00688987 |
Other Study ID Numbers: |
eIRB 545 OCTRI #711 |
First Posted: | June 3, 2008 Key Record Dates |
Last Update Posted: | June 5, 2008 |
Last Verified: | June 2008 |
Obesity Addison Disease Overnutrition Nutrition Disorders Overweight Body Weight Adrenal Insufficiency |
Adrenal Gland Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Hydrocortisone Anti-Inflammatory Agents |