Status:
COMPLETED
Effects of Testosterone Gel on Carbohydrate and Lipid Metabolism In Elderly Obese Men
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
Solvay Pharmaceuticals
Conditions:
Aging
Obesity
Eligibility:
MALE
60-90 years
Phase:
PHASE2
Brief Summary
A. HYPOTHESES: In older men low testosterone levels, abdominal obesity and elevated fasting insulin who are at risk for the cardiovascular complications such as heart attack and stroke. 1. Supplement...
Detailed Description
Study Design: This is an investigator-initiated open label, study to investigate the effects of supplemental testosterone (gel formulation) to increase testosterone levels to the upper normal range in...
Eligibility Criteria
Inclusion
- Entry Criteria:
- Men \> 60 years of age
- Total testosterone \< 300 ng/dL
- Waist circumference \>102 cm
- Fasting insulin level \> 18 U/L
Exclusion
- PSA \> 4.1, symptoms of obstructive uropathy (AUA score \> 14), unexplained prostate nodule or gland firmness
- Hematocrit \> 50%
- Malignancy other than cutaneous cancers
- Sleep apnea requiring CPAP
- History of myocardial infarction, angina or stroke within the previous 6 months
- Clinical diagnosis of diabetes or FPG \> 126 mg/dL
- Hypothyroidism not controlled to euthyroid levels with medication for at least 3 months
- LDL-C \>160 mg/dL
- Transaminases \> 1.5X ULN
- Systemic anticoagulation with warfarin
- Active progressive resistance training
- Dieting for weight loss
- Active inflammatory condition (e.g. rheumatoid arthritis)
- Use of any anabolic agent (e.g. growth hormone, testosterone precursor, anabolic steroid)or cytokine therapy in the proceeding 12 months
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00365794
Start Date
August 1 2006
End Date
December 1 2014
Last Update
August 26 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
LAC-USC Medical Center GCRC
Los Angeles, California, United States, 90033