Effect of Increasing Testosterone on Insulin Sensitivity in Men With the Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

Effect of Increasing Testosterone on Insulin Sensitivity in Men With the Metabolic Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00438321
• Other study ID #: 2003-P-001526
• Status: Terminated
• Phase: Phase 1
• First received: February 20, 2007
• Last updated: April 14, 2017
• Start date: September 2006
• Est. completion date: February 26, 2010

Study information

• Verified date: April 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 66
• Est. completion date: February 26, 2010
• Est. primary completion date: February 26, 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• Zoladex

• Testosterone gel

• Anastrozole Pill

Other:
• Placebo

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	American Diabetes Association, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Pitteloud N, Hardin M, Dwyer AA, Valassi E, Yialamas M, Elahi D, Hayes FJ. Increasing insulin resistance is associated with a decrease in Leydig cell testosterone secretion in men. J Clin Endocrinol Metab. 2005 May;90(5):2636-41. Epub 2005 Feb 15. — View Citation

Pitteloud N, Mootha VK, Dwyer AA, Hardin M, Lee H, Eriksson KF, Tripathy D, Yialamas M, Groop L, Elahi D, Hayes FJ. Relationship between testosterone levels, insulin sensitivity, and mitochondrial function in men. Diabetes Care. 2005 Jul;28(7):1636-42. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity	Assessed by euglycemic-hyperinsulinemic clamp	3 months
Secondary	Resting energy expenditure	Indirect calorimetry	3 months
Secondary	Lipid profile	Fasting lipids	3 months
Secondary	Body composition	DXA scan	3 months
Secondary	Intramyocellular fat	MR spectroscoopy	3 months

External Links

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