Overview

This trial is active, not recruiting.

Conditions obesity, insulin resistance
Treatments anastrazole, testosterone, dutasteride, gnrh antagonist
Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator University of California, San Diego
Start date June 2005
End date May 2009
Trial size 57 participants
Trial identifier NCT00983554, DK65038 (completed)

Summary

Subjects will be randomized into 4 study groups: 1. Placebo; 2. Anastrazole and Testosterone; 3. Dutasteride and Testosterone; and 4. Testosterone only. A 2 step euglycemic clamp, body composition by dual X-ray absorptiometry scan, hormone and lipid assays will be performed to monitor metabolic effects of each treatment group. We hypothesize that increasing testosterone levels would increase lean mass, decrease fat mass and improve insulin sensitivity. We further hypothesize that improvements in the metabolic profile would decrease with anastrazole and improve with dutasteride, given in conjunction with T administration.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(No Intervention)
(Experimental)
anastrazole
Arimidex 1mg daily
testosterone
Testim 10g daily
dutasteride
Avodart 2.5mg daily
gnrh antagonist
Acyline 300 µg/kg subcutaneous injections every 2 weeks
(Experimental)
testosterone
Testim 10g daily
dutasteride
Avodart 2.5mg daily
gnrh antagonist
Acyline 300 µg/kg subcutaneous injections every 2 weeks
(Experimental)
testosterone
Testim 10g daily
dutasteride
Avodart 2.5mg daily
gnrh antagonist
Acyline 300 µg/kg subcutaneous injections every 2 weeks

Primary Outcomes

Measure
insulin sensitivity
time frame: 14 weeks

Secondary Outcomes

Measure
body composition
time frame: 14 weeks
lipid profile
time frame: 14 weeks

Eligibility Criteria

Male participants from 24 years up to 51 years old.

Inclusion Criteria: - free T level in the lower 25% of the normal range or below - BMI ≥30kg/m2 - waist circumference ≥100cm Exclusion Criteria: - pituitary tumors - HIV infection - Klinefelter's syndrome - Kallman's syndrome - uncontrolled hypertension - diabetes - congestive heart failure - chronic lung disease - acute coronary syndrome - PSA >4µg/L - aspartate aminotransferase (AST)> 3x upper limit of normal - use of medications that might affect weight loss, muscle or bone metabolism or androgen metabolism, action or clearance. - involvement in daily resistance training or high endurance exercise - alcohol or drug dependence - obstructive sleep apnea

Additional Information

Official title Metabolic Effects of Testosterone Alone or in Combination With Dutasteride or Anastrazole in Obese Men
Principal investigator Karen L Herbst, PhD, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2011.
Information provided to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).