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Sponsors and Collaborators: |
Diabetes Center of the Southwest Solvay Pharmaceuticals |
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Information provided by: | Diabetes Center of the Southwest |
ClinicalTrials.gov Identifier: | NCT00440440 |
The purpose of the study is to find out the effect of replacing testosterone in the form of a gel (Androgel®) on the amount of fat mass in males with low testosterone and diabetes.
Condition | Intervention | Phase |
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Hypogonadism Diabetes |
Drug: Testosterone gel Drug: placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Effect of Androgel on Total and Regional Adipose Tissue and Lean Body Mass in Type 2 Diabetic Patients With Hypogonadism |
Estimated Enrollment: | 52 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
testosterone gel
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Drug: Testosterone gel
Testosterone gel to be applied daily, starting does 5g.
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2: Placebo Comparator
placebo gel
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Drug: placebo
placebo gel apply daily
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Hypogonadism is associated with increase in fat mass, decrease in muscle mass, accelerated bone loss, decreased libido and effects on mood. Androgen replacement in this context is clearly beneficial, and numerous studies have demonstrated improvements in bone and muscle mass, reductions in body fat and improvement in insulin sensitivity, libido and mood following treatment. Testosterone replacement leads to a dose-dependent decrease in adipose tissue and increase in muscle mass and strength. The principal focus of the proposed research is to evaluate the effect of androgel on lean body mass and regional adipose tissue mass (including hepatic and visceral fat) in type 2 diabetic patients with hypogonadism, a population that is likely to benefit from a reduction in adipose tissue and an increase in muscle mass.
Ages Eligible for Study: | 35 Years to 75 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sandeep Dhindsa, MBBS | 432-686-0000 | sandhindsa@yahoo.com |
United States, Texas | |
Diabetes Center of the Southwest | |
Midland, Texas, United States, 79707 |
Principal Investigator: | Sandeep Dhindsa, MBBS | Diabetes Center of the Southwest |
Responsible Party: | Department of Endocrinology and Metabolism ( sandeep dhindsa ) |
Study ID Numbers: | GR-940 |
Study First Received: | February 23, 2007 |
Last Updated: | May 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00440440 |
Health Authority: | United States: Institutional Review Board |
hypogonadism diabetes visceral fat hepatic fat lean mass |
Testosterone Metabolic Diseases Hypogonadism Gonadal Disorders Diabetes Mellitus Endocrine System Diseases |
Methyltestosterone Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Testosterone 17 beta-cypionate |
Anabolic Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions Androgens |