Metabolic Syndrome
Conditions
Keywords
Overweight, obesity, testosterone, diabetes, metabolic syndrome, aging
Brief summary
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.
Detailed description
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.
Interventions
Sponsors
National Institutes of Health (NIH)
American Diabetes Association
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Stable weight for previous three months (no weight change greater than or equal to +/-10 lbs)
Exclusion criteria
* No new diagnosis of type 2 diabetes or on oral hypoglycemic agents * No history of testicular disorders * No history of bleeding disorders (i.e. Pulmonary Embolism, Deep Vein Thrombosis, stroke, hypercoagulable syndrome) * No history of prostate cancer * No previous diagnosis of osteoporosis * No history of sleep apnea (subjects will also be excluded if at their baseline assessment they admit to heavy snoring, restless sleep, and/or excessive daytime somnolence) * No symptoms of urinary outflow obstruction or medications for prostate disease * No illicit drug use or heavy alcohol use (\>4 drinks/day)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin sensitivity | 3 months | Assessed by euglycemic-hyperinsulinemic clamp |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resting energy expenditure | 3 months | Indirect calorimetry |
| Lipid profile | 3 months | Fasting lipids |
| Body composition | 3 months | DXA scan |
| Intramyocellular fat | 3 months | MR spectroscoopy |
Countries
United States
Outcome results
None listed