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| Descriptive Information Fields | |||||||||
| Brief Title † | Biologic Effects of Dehydroepiandrosterone (DHEA) in Humans | ||||||||
| Official Title † | Biologic Effects of DHEA in Humans | ||||||||
| Brief Summary | The purpose of this study is to determine whether DHEA replacement therapy decreases abdominal fat and improves insulin sensitivity. |
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| Detailed Description | Studies on rats and mice have shown that the adrenal hormone dehydroepiandrosterone (DHEA) reduces abdominal visceral fat and protects against insulin resistance. This study was done to learn if DHEA replacement therapy decreases abdominal obesity and improves insulin action in humans. Participants were randomly assigned to receive 50 mg per day of DHEA or a placebo at bedtime for 6 months. Participants underwent magnetic resonance imaging (MRI) and oral glucose tolerance tests at the beginning and conclusion of the study. Other tests included measurements of hormones and lipids. |
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Prevention, Randomized, Double-Blind, Placebo Control | ||||||||
| Primary Outcome Measure † | 6-month change in visceral and subcutaneous abdominal fat | ||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | Aging Obesity Insulin Resistance |
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| Intervention † | Drug: DHEA | ||||||||
| MEDLINE PMIDs | 15536111, 9374813, 9467418, 11106916 | ||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Completed | ||||||||
| Enrollment † | 56 | ||||||||
| Start Date † | June 2001 | ||||||||
| Completion Date | February 2004 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 65 Years to 78 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00099697 | ||||||||
| Organization ID | AG0013 | ||||||||
| Secondary IDs †† | 5P60AG013629, 5R01AG020076, 5K23RR016191, 3P30DK056341, 5P60DK020579, 2M01RR000036 | ||||||||
| Study Sponsor † | National Institute on Aging (NIA) | ||||||||
| Collaborators †† | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Center for Research Resources (NCRR) |
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| Investigators † |
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| Information Provided By | National Institute on Aging (NIA) | ||||||||
| Verification Date | December 2004 | ||||||||
| First Received Date † | December 17, 2004 | ||||||||
| Last Updated Date | June 23, 2005 | ||||||||
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