Effect of Increasing Testosterone on Insulin Sensitivity in Men With the Metabolic Syndrome
Recruitment status was Recruiting
The purpose of the study is to examine the effect of testosterone treatment on insulin in men with the metabolic syndrome with testosterone levels at or below the lower end of the normal range.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Effect of Increasing Testosterone on Insulin Sensitivity in Men With the Metabolic Syndrome|
- Fasting Insulin
- Fasting Glucose
- cholesterol, HDL, LDL, triglycerides
- SHBG, LH, FSH, PRL, TSH
- percent body fat
- Resting Metabolic Rate
- Aerobic capacity
|Study Start Date:||September 2006|
|Estimated Study Completion Date:||September 2010|
|Estimated Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
The metabolic syndrome is a medical condition defined by high cholesterol levels, high blood pressure, increased abdominal obesity (gain in fat around the region of the stomach), and insulin resistance. Insulin is the hormone that your body produces to decrease the levels of sugar in your blood. A person that is insulin resistant needs more insulin to decrease blood sugar levels than a normal person does. Insulin resistance can lead to type 2 diabetes, which is one of the most common illnesses in the United States.
There is evidence pointing to a relationship between insulin and testosterone in men (testosterone is the male sex hormone that is produced in the testes). As men get older their testosterone levels decrease while their weight and insulin resistance tends to increase. The purpose of this research study is to learn more about the details of the relationship between insulin and testosterone. A clearer understanding of this relationship can have an important impact on public health due to the high rate of health problems associated with diabetes, obesity, and heart disease.
We are looking for men between the ages of 50-75 with the metabolic syndrome to participate in this research study. Participation in this study involves taking medication and/or placebo (a placebo looks exactly like the study medication but contains no active drug), blood tests, muscle biopsies, and imaging scans. This study involves outpatient visits. Subjects are paid up to $500 for completing the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00438321
|Contact: Lindsay A Edwardsfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator: Frances J Hayes, MD|
|Principal Investigator:||Frances J Hayes, MD||Massachusetts General Hospital|