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Metabolic Effects of Androgenicity in Aging Men and Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00680797
First Posted: May 20, 2008
Last Update Posted: June 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
May 8, 2008
May 20, 2008
July 24, 2014
March 21, 2016
June 15, 2017
January 1, 2005
December 31, 2013   (Final data collection date for primary outcome measure)
Insulin Sensitivity [ Time Frame: 6 weeks ]
As measured by change in insulin levels pre- and post-hormone changes
Insulin Sensitivity [ Time Frame: 6 weeks ]
Complete list of historical versions of study NCT00680797 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Metabolic Effects of Androgenicity in Aging Men and Women
Metabolic Effects of Androgenicity in Aging Men and Women

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Aging
  • Insulin Resistance
  • Drug: Testosterone
    Testosterone gel
  • Drug: Estrogen
    Estrogen patch
  • Experimental: +T +E
    +Testosterone, +Estrogen
    Interventions:
    • Drug: Testosterone
    • Drug: Estrogen
  • Experimental: +T -E
    +Testosterone, -Estrogen
    Intervention: Drug: Testosterone
  • Experimental: -T +E
    -Testosterone, +Estrogen
    Intervention: Drug: Estrogen
  • No Intervention: -T -E
    -Testosterone, -Estrogen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
December 31, 2016
December 31, 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • males age 60-85 years
  • non-diabetic fasting glucose and 2-hour oral glucose tolerance test (OGTT)
  • overall good general medical health and signed informed consent
  • willing to travel to West Los Angeles VA and University of California, Los Angeles in Los Angeles, California

Exclusion Criteria:

  • any clinically significant abnormalities detected on screening physical exam or laboratory testing (e.g. prostate specific antigen > 4)
  • or other symptom or history of a significant underlying medical or psychiatric illness
  • BMI < 20 or > 40
  • subjects already on testosterone therapy or medications that might influence glucose regulation or hormone levels
  • subjects with a history of deep venous thromboses, pulmonary embolism, breast cancer, prostate cancer, polycythemia or other contraindications to estrogen or testosterone
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
60 Years to 85 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00680797
ARCD-034-04F
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: Undecided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Cathy C Lee, PhD VA Greater Los Angeles Healthcare System, West Los Angeles, CA
VA Office of Research and Development
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP