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

Mass General Brigham

Status and phase: Terminated; Phase 1

Conditions: Metabolic Syndrome

Treatments: Drug: Zoladex; Other: Placebo; Drug: Testosterone gel; Drug: Anastrozole Pill

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00438321

2003-P-001526

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: Male

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo injection, gel and pill

Treatment:

Other: Placebo

Testosterone only

Active Comparator group

Description:

Zoladex 3.6 mg IM injection Testosterone 7.5 g gel (AndroGel) transdermally daily Anastrozole 10 mg (Arimidex) orally daily

Treatment:

Drug: Anastrozole Pill

Drug: Testosterone gel

Drug: Zoladex

Testosterone and Estrogen

Active Comparator group

Description:

Zoladex 3.6 mg IM injection Testosterone 7.5 g gel (AndroGel) transdermally Placebo pill orally daily

Treatment:

Drug: Testosterone gel

Drug: Zoladex