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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Massachusetts General Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
American Diabetes Association
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00438321
First received: February 20, 2007
Last updated: May 3, 2010
Last verified: May 2010
  Purpose

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 Intervention
Metabolic Syndrome
Drug: Zoladex
Drug: AndroGel
Drug: Arimidex

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effect of Increasing Testosterone on Insulin Sensitivity in Men With the Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Fasting Insulin
  • Fasting Glucose
  • Testosterone
  • Estradiol

Secondary Outcome Measures:
  • cholesterol, HDL, LDL, triglycerides
  • SHBG, LH, FSH, PRL, TSH
  • cytokines
  • percent body fat
  • Resting Metabolic Rate
  • Aerobic capacity

Estimated Enrollment: 72
Study Start Date: September 2006
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00438321

Contacts
Contact: Lindsay A Edwards 617-726-8436 ledwards@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Frances J Hayes, MD         
Sponsors and Collaborators
Massachusetts General Hospital
American Diabetes Association
Investigators
Principal Investigator: Frances J Hayes, MD Massachusetts General Hospital
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00438321     History of Changes
Other Study ID Numbers: 2003-P-001526
Study First Received: February 20, 2007
Last Updated: May 3, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Overweight
obesity
testosterone
diabetes
metabolic syndrome
aging

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Goserelin
Anastrozole
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014