Testosterone Effects on Men With the Metabolic Syndrome

NCT00382057 | Withdrawn Phase 2

• 3 other identifiers: 5 K23 DK02858-15265 K23 DK02858-02 6/15/055K23DK002858-02
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

The metabolic syndrome is a medical condition defined by high levels of cholesterol in the blood, high blood pressure, central obesity (gain in fat around the region of the stomach), and insulin resistance (body responds less well to insulin). This state of impaired insulin resistance can lead to type 2 diabetes mellitus, which is one of the most common metabolic disorders in the U.S. Numerous studies have shown an inverse relationship between insulin resistance and testosterone levels in men, however, causality has not been established. This protocol investigates the role of testosterone in modulating insulin sensitivity in insulin resistant states such as the metabolic syndrome. The hypothesis is that testosterone administration will improve insulin sensitivity.

Conditions

Metabolic Syndrome

Keywords

Testosterone; Insulin resistance; Insulin sensitivity; Metabolic disorders

Outcome Measures

Primary Outcomes (5)

• insulin sensitivity

• muscle and body fat distribution

• VO2 max

• resting metabolic rate

• muscle biopsy analysis

Interventions

Testosterone DRUG

Anastrozole DRUG

Goserelin DRUG

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50-75 yr
• Diagnosis of the metabolic syndrome defined by the American Heart Association/National Heart, Lung, and Blood Institute guidelines as the presence of three or more of the following:
• Waist circumference \> 102 cm
• Serum triglycerides \> 150 mg/dL
• HDL cholesterol \< 40 mg/dL
• Blood pressure \> 130 mm Hg systolic or 85 mm Hg diastolic, or treatment with anti-hypertensives
• Fasting serum glucose \> 100 mg/dL
• Plasma total testosterone level less than 300 ng/dL (1 SD below the mean for young healthy men)
• Stable weight for previous three months (no weight change greater than or equal to +/-10 lbs)
• Normal TSH, prolactin and prostate specific antigen (PSA) levels (\<2.5 ng/mL)

You may not qualify if:

• New diagnosis of type 2 diabetes as defined by the ADA criteria: fasting glucose greater than 126 mg/dL or random blood glucose greater than 200 mg/dL on two occasions, or on oral hypoglycemic agents
• History of testicular disorders (i.e. cryptorchidism)
• History of bleeding disorders (i.e. thrombocytopenia) or baseline hemoglobin levels less than 12g/dL
• History of prostate cancer
• 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)
• Symptoms of urinary outflow obstruction (i.e. benign prostatic hypertrophy)
• Illicit drug use or heavy alcohol use (\>4 drinks/day)
• Allergic disorders
• Current medications (must exclude individuals taking the following medications: Testosterone, Cimetidine, Spironolactone, Ketoconazole, Finasteride, DHEA, Androstenedione, Oral steroids, GnRH analogs)

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance; Metabolic Diseases

Interventions

Testosterone; Anastrozole; Goserelin

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• William F Crowley, MD

  Massachusetts General Hospital

  STUDY DIRECTOR

• Frances J Hayes, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 26, 2006
• First Posted: September 28, 2006
• Study Start: May 1, 2006
• Study Completion: March 1, 2011
• Last Updated: December 5, 2008

Record last verified: 2008-11