NCT00983554

Metabolic Effects of Steroids in Obese Men

Metabolic Effects of Testosterone Alone or in Combination With Dutasteride or Anastrazole in Obese Men

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: Male
• Age: 24 Years – 51 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity
• Insulin Resistance

Interventions

Type	Name	Description
DRUG	Anastrazole	Arimidex 1mg daily
DRUG	Testosterone	Testim 10g daily
DRUG	Dutasteride	Avodart 2.5mg daily
DRUG	GnRH antagonist	Acyline 300 µg/kg subcutaneous injections every 2 weeks

Timeline

• Start date: 2005-06-01
• Primary completion: 2009-05-01
• Completion: 2009-10-01
• First posted: 2009-09-24
• Last updated: 2011-03-16

Locations

2 sites across 1 country: United States