View Clinical Trial (Medical Research Study)
Effect of Increasing Testosterone on Insulin Sensitivity in Men With the Metabolic Syndrome
| City: |
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02114 |
| Conditions: |
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Metabolic Syndrome |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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)
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| NCT ID: |
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NCT00438321 |
| Primary Contact: |
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Principal Investigator
Frances J Hayes, MD
Massachusetts General Hospital
Lindsay A Edwards
Phone: 617-726-8436
Email: ledwards@partners.org
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| Backup Contact: |
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N/A |
| Location Contact: |
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Boston, Massachusetts 02114
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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