An interventional study of Hydrocortisone and Isocaloric Diet in Obesity and Addison's Disease, sponsored by Oregon Health and Science University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-06-05.
Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Treatment
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.
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.
6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's enrollment of 24 is below the median of 77 across 5,084 interventional studies indexed under Obesity.
Browse Obesity studies →Oregon Health and Science University is the lead sponsor of 694 studies on the registry; 133 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 39 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects with AI will be randomized to each of three doses of hydrocortisone for 4 months on each dose.
Drug: Hydrocortisone
isocaloric diet
Dietary Supplement: Isocaloric Diet
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
Also known as: 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
The record gives a start of Aug 2000, a primary completion of Jul 2004 and a completion of Aug 2004. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Hydrocortisone
Oregon Health and Science University →