Metabolic Effects of Androgenicity in Aging Men and Women

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00680797
First received: May 8, 2008
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Aging
Insulin Resistance
Drug: Testosterone
Drug: Estrogen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Metabolic Effects of Androgenicity in Aging Men and Women

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Insulin Sensitivity [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2005
Estimated Study Completion Date: February 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
+Testosterone, +Estrogen
Drug: Testosterone
Testosterone gel
Drug: Estrogen
Estrogen patch
Experimental: Arm 2
+Testosterone, -Estrogen
Drug: Testosterone
Testosterone gel
Experimental: Arm 3
-Testosterone, +Estrogen
Drug: Estrogen
Estrogen patch
No Intervention: Arm 4
-Testosterone, -Estrogen

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680797

Locations
United States, California
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
Investigators
Principal Investigator: Cathy Lee, PhD VA Greater Los Angeles Healthcare System, West LA
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00680797     History of Changes
Other Study ID Numbers: ARCD-034-04F
Study First Received: May 8, 2008
Last Updated: February 7, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Aging
Hormones
Insulin resistance

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Estrogens
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on August 25, 2014