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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00438321
Recruitment Status : Terminated (PI relocated)
First Posted : February 22, 2007
Last Update Posted : April 18, 2017
National Institutes of Health (NIH)
American Diabetes Association
Information provided by (Responsible Party):
Frances Hayes, 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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Drug: Zoladex Drug: Testosterone gel Drug: Anastrozole Pill Other: Placebo Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effect of Increasing Testosterone on Insulin Sensitivity in Men With the Metabolic Syndrome
Study Start Date : September 2006
Actual Primary Completion Date : February 26, 2010
Actual Study Completion Date : February 26, 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo injection, gel and pill
Other: Placebo
Active Comparator: Testosterone only
Zoladex 3.6 mg IM injection Testosterone 7.5 g gel (AndroGel) transdermally daily Anastrozole 10 mg (Arimidex) orally daily
Drug: Zoladex
Drug: Testosterone gel
Other Name: AndroGel

Drug: Anastrozole Pill
Other Name: Arimidex

Active Comparator: Testosterone and Estrogen
Zoladex 3.6 mg IM injection Testosterone 7.5 g gel (AndroGel) transdermally Placebo pill orally daily
Drug: Zoladex
Drug: Testosterone gel
Other Name: AndroGel

Primary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: 3 months ]
    Assessed by euglycemic-hyperinsulinemic clamp

Secondary Outcome Measures :
  1. Resting energy expenditure [ Time Frame: 3 months ]
    Indirect calorimetry

  2. Lipid profile [ Time Frame: 3 months ]
    Fasting lipids

  3. Body composition [ Time Frame: 3 months ]
    DXA scan

  4. Intramyocellular fat [ Time Frame: 3 months ]
    MR spectroscoopy

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00438321

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
American Diabetes Association
Principal Investigator: Frances J Hayes, MD Massachusetts General Hospital

Additional Information:
Responsible Party: Frances Hayes, Associate Professor, Massachusetts General Hospital Identifier: NCT00438321     History of Changes
Other Study ID Numbers: 2003-P-001526
First Posted: February 22, 2007    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Frances Hayes, Massachusetts General Hospital:
metabolic syndrome

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Hypoglycemic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists