Metabolic Effects of Androgenicity in Aging Men and Women
Primary Purpose
Aging, Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Testosterone
Estrogen
Sponsored by
About this trial
This is an interventional basic science trial for Aging focused on measuring Aging, Hormones, Insulin resistance
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
Sites / Locations
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
+T +E
+T -E
-T +E
-T -E
Arm Description
+Testosterone, +Estrogen
+Testosterone, -Estrogen
-Testosterone, +Estrogen
-Testosterone, -Estrogen
Outcomes
Primary Outcome Measures
Insulin Sensitivity
As measured by change in insulin levels pre- and post-hormone changes
Secondary Outcome Measures
Full Information
NCT ID
NCT00680797
First Posted
May 8, 2008
Last Updated
May 22, 2017
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT00680797
Brief Title
Metabolic Effects of Androgenicity in Aging Men and Women
Official Title
Metabolic Effects of Androgenicity in Aging Men and Women
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2005 (Actual)
Primary Completion Date
December 31, 2013 (Actual)
Study Completion Date
December 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Insulin Resistance
Keywords
Aging, Hormones, Insulin resistance
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
+T +E
Arm Type
Experimental
Arm Description
+Testosterone, +Estrogen
Arm Title
+T -E
Arm Type
Experimental
Arm Description
+Testosterone, -Estrogen
Arm Title
-T +E
Arm Type
Experimental
Arm Description
-Testosterone, +Estrogen
Arm Title
-T -E
Arm Type
No Intervention
Arm Description
-Testosterone, -Estrogen
Intervention Type
Drug
Intervention Name(s)
Testosterone
Intervention Description
Testosterone gel
Intervention Type
Drug
Intervention Name(s)
Estrogen
Intervention Description
Estrogen patch
Primary Outcome Measure Information:
Title
Insulin Sensitivity
Description
As measured by change in insulin levels pre- and post-hormone changes
Time Frame
6 weeks
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cathy C Lee, PhD
Organizational Affiliation
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Metabolic Effects of Androgenicity in Aging Men and Women
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