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OpenTrials
Completed

NCT Number: NCT00680797

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.

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Key information

Age range

60 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

West Los Angeles, California, 90073, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Testosterone

Drug

Testosterone gel

Estrogen

Drug

Estrogen patch

Primary outcomes

  1. Insulin Sensitivity

    Time frame: 6 weeks

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

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2005
Primary completion
2013
Study completion
2016
First posted
May 20, 2008
Registry last updated
Jun 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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