Metabolic Effects of Androgenicity in Aging Men and Women

Aging Clinical Trial

Official title:

Metabolic Effects of Androgenicity in Aging Men and Women

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00680797
• Other study ID #: ARCD-034-04F
• Status: Active, not recruiting
• Phase: N/A
• First received: May 8, 2008
• Last updated: February 7, 2014
• Start date: January 2005
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

We 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. PSA > 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: February 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 60 Years to 85 Years

Eligibility

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 LA VA and UCLA in Los Angeles, CA

Exclusion Criteria:

• any clinically significant abnormalities detected on screening physical exam or laboratory testing (e.g. PSA > 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Aging
• Insulin Resistance

Intervention

Drug:
• Testosterone
Testosterone gel
• Estrogen
Estrogen patch

Locations

Country	Name	City	State
United States	VA Greater Los Angeles Healthcare System, West LA	West Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin Sensitivity		6 weeks	No