Metabolic Effects of Androgenicity in Aging Men and Women

NCT ID: NCT00680797

Last Updated: 2017-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-01
• Study Completion Date: 2016-12-31

Brief 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.

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.

Conditions

Aging; Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

+T +E

+Testosterone, +Estrogen

Group Type: EXPERIMENTAL

Testosterone

Intervention Type: DRUG

Testosterone gel

Estrogen

Intervention Type: DRUG

Estrogen patch

+T -E

+Testosterone, -Estrogen

Group Type: EXPERIMENTAL

Testosterone

Intervention Type: DRUG

Testosterone gel

-T +E

-Testosterone, +Estrogen

Group Type: EXPERIMENTAL

Estrogen

Intervention Type: DRUG

Estrogen patch

-T -E

-Testosterone, -Estrogen

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Testosterone

Testosterone gel

Intervention Type: DRUG

Estrogen

Estrogen patch

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cathy C Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Locations

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, United States

Countries

United States

Other Identifiers

ARCD-034-04F

Identifier Type: -

Identifier Source: org_study_id