Metabolic Effects of Androgenicity in Aging Men and Women
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|ClinicalTrials.gov Identifier: NCT00680797|
Recruitment Status : Completed
First Posted : May 20, 2008
Results First Posted : March 21, 2016
Last Update Posted : June 15, 2017
The goal of this research study is to study the effect of testosterone or estrogen on blood sugar control and fat metabolism. Changes in hormone levels with age may affect risk factors for heart disease such as diabetes. Diabetes is a glandular condition associated with lack of the hormone insulin or an insensitivity to it resulting in problems with blood sugar control and fat metabolism. The effect of commonly used hormonal supplements such as testosterone by older adults on insulin and body composition is not well understood. In this study, the role of testosterone and estrogen on your ability to control blood sugar and your body composition will be assessed.
The investigators plan to study 60 subjects. All of these subjects will be healthy older men between the ages of 60-85 years old who are not on testosterone therapy. Subjects that are screened who have any clinically significant abnormalities detected on their screening physical exam or laboratory testing (e.g. Prostate Specific Antigen > 4), who have a history of prostate cancer, polycythemia, or who cannot take testosterone will not be included.
If a subject is eligible to participate after initial screening, that subject will take medications to adjust their hormone levels and have tests performed that measure insulin sensitivity and adiposity before and after these hormone medications. The outcomes that will be measured are: 1) insulin sensitivity, 2) hormone levels (total and free testosterone levels, sex hormone-binding globulin levels) and 3) body composition and abdominal adiposity.
|Condition or disease||Intervention/treatment||Phase|
|Aging Insulin Resistance||Drug: Testosterone Drug: Estrogen||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Metabolic Effects of Androgenicity in Aging Men and Women|
|Actual Study Start Date :||January 1, 2005|
|Actual Primary Completion Date :||December 31, 2013|
|Actual Study Completion Date :||December 31, 2016|
Experimental: +T +E
Testosterone gelDrug: Estrogen
Experimental: +T -E
Experimental: -T +E
No Intervention: -T -E
- Insulin Sensitivity [ Time Frame: 6 weeks ]As measured by change in insulin levels pre- and post-hormone changes
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): NCT00680797
|United States, California|
|VA Greater Los Angeles Healthcare System, West Los Angeles, CA|
|West Los Angeles, California, United States, 90073|
|Principal Investigator:||Cathy C Lee, PhD||VA Greater Los Angeles Healthcare System, West Los Angeles, CA|