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

Phase 1

Terminated

• Conditions: Metabolic Syndrome
• Interventions: Drug: Zoladex; Other: Placebo; Drug: Testosterone gel; Drug: Anastrozole Pill

• Registration Number: NCT00438321
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-02-20
• Study First Submitted QC: 2007-02-20
• Study First Posted: 2007-02-22
• Primary Completion: 2010-02-26
• Study Completion: 2010-02-26
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-14
• Last Update Posted: 2017-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 66

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Testosterone only	Zoladex	Zoladex 3.6 mg IM injection Testosterone 7.5 g gel (AndroGel) transdermally daily Anastrozole 10 mg (Arimidex) orally daily
Placebo	Placebo	Placebo injection, gel and pill
Testosterone only	Anastrozole Pill	Zoladex 3.6 mg IM injection Testosterone 7.5 g gel (AndroGel) transdermally daily Anastrozole 10 mg (Arimidex) orally daily
Testosterone and Estrogen	Testosterone gel	Zoladex 3.6 mg IM injection Testosterone 7.5 g gel (AndroGel) transdermally Placebo pill orally daily
Testosterone only	Testosterone gel	Zoladex 3.6 mg IM injection Testosterone 7.5 g gel (AndroGel) transdermally daily Anastrozole 10 mg (Arimidex) orally daily
Testosterone and Estrogen	Zoladex	Zoladex 3.6 mg IM injection Testosterone 7.5 g gel (AndroGel) transdermally Placebo pill orally daily

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity	3 months	Assessed by euglycemic-hyperinsulinemic clamp

Secondary Outcome Measures

Name	Time	Method
Body composition	3 months	DXA scan
Resting energy expenditure	3 months	Indirect calorimetry
Lipid profile	3 months	Fasting lipids
Intramyocellular fat	3 months	MR spectroscoopy

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States