Metabolic Effects of Androgenicity in Aging Men and Women

NCT00680797 | Completed Results DMC

• 1 other identifier: ARCD-034-04F
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Keywords

Aging; Hormones; Insulin resistance

Outcome Measures

Primary Outcomes (1)

• Insulin Sensitivity

  As measured by change in insulin levels pre- and post-hormone changes

  6 weeks

Study Arms (4)

+T +E

EXPERIMENTAL

+Testosterone, +Estrogen

Drug: Testosterone; Drug: Estrogen

+T -E

EXPERIMENTAL

+Testosterone, -Estrogen

Drug: Testosterone

-T +E

EXPERIMENTAL

-Testosterone, +Estrogen

Drug: Estrogen

-T -E

NO INTERVENTION

-Testosterone, -Estrogen

Interventions

Testosterone DRUG

Testosterone gel

+T +E; +T -E

Estrogen DRUG

Estrogen patch

+T +E; -T +E

Eligibility Criteria

• Age: 60 Years - 85 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

West Los Angeles, California, 90073, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Testosterone; Estrogens

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Limitations and Caveats

Small sample size may limit generalizability of these results. Follow-up studies are being conducted to further evaluate these results.

Results Point of Contact

• Title: Dr. Cathy Lee
• Organization: VA Greater Los Angeles

cathy.lee2@va.gov

310-478-3711

Study Officials

• Cathy C Lee, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2008
• First Posted: May 20, 2008
• Study Start: January 1, 2005
• Primary Completion: December 31, 2013
• Study Completion: December 31, 2016
• Last Updated: June 15, 2017
• Results First Posted: March 21, 2016

Record last verified: 2017-05

Locations

US (1)