Metabolic Effects of Steroids in Obese Men

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00983554

Enrollment

Registered

2009-09-24

Start date

2005-06-30

Completion date

2009-10-31

Last updated

2011-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Insulin Resistance

Keywords

testosterone, insulin, obesity, aromatase, 5 alpha reductase

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.

Interventions

DRUGAnastrazole

Arimidex 1mg daily

DRUGTestosterone

Testim 10g daily

DRUGDutasteride

Avodart 2.5mg daily

DRUGGnRH antagonist

Acyline 300 µg/kg subcutaneous injections every 2 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

24 Years to 51 Years

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

Design outcomes

Primary

Measure	Time frame
insulin sensitivity	14 weeks

Secondary

Measure	Time frame
body composition	14 weeks
lipid profile	14 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026