Metabolic Effects of Steroids in Obese Men

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

Overall Status

Unknown status

CT.gov ID

NCT00983554

Collaborator

University of California, San Diego (Other)

Enrollment

Locations

Arms

Duration (Months)

28.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Insulin Resistance	Drug: Anastrazole Drug: Testosterone Drug: Dutasteride Drug: GnRH antagonist	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

57 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2005

Actual Primary Completion Date :

May 1, 2009

Anticipated Study Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Placebo
Experimental: Anastrazole and Testosterone	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
Experimental: Dutasteride and Testosterone	Drug: Testosterone Testim 10g daily Drug: Dutasteride Avodart 2.5mg daily Drug: GnRH antagonist Acyline 300 µg/kg subcutaneous injections every 2 weeks
Experimental: Testosterone	Drug: Testosterone Testim 10g daily Drug: Dutasteride Avodart 2.5mg daily Drug: GnRH antagonist Acyline 300 µg/kg subcutaneous injections every 2 weeks

Outcome Measures

Primary Outcome Measures

insulin sensitivity [14 weeks]

Secondary Outcome Measures

body composition [14 weeks]
lipid profile [14 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

24 Years to 51 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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