Effect of Increasing Testosterone on Insulin Sensitivity in Men With the Metabolic Syndrome - Full Text View

Sponsor:	Massachusetts General Hospital
Collaborators:	National Institutes of Health (NIH) American Diabetes Association
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00438321

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:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Increasing Testosterone on Insulin Sensitivity in Men With the Metabolic Syndrome

Resource links provided by NLM:

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Insulin Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

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:	June 2011

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

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

National Institutes of Health (NIH)

American Diabetes Association

Investigators

Principal Investigator:

Frances J Hayes, MD

Massachusetts General Hospital

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

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.

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.

Study ID Numbers:	2003-P-001526
Study First Received:	February 20, 2007
Last Updated:	February 20, 2007
ClinicalTrials.gov Identifier:	NCT00438321 History of Changes
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:

Disease
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Methyltestosterone
Hormones
Pharmacologic Actions

Testosterone 17 beta-cypionate
Anabolic Agents
Testosterone
Pathologic Processes
Therapeutic Uses
Syndrome
Androgens

ClinicalTrials.gov processed this record on February 08, 2010