Metabolic Effects of Steroids in Obese Men

Condition(s) targeted: Obesity; Insulin Resistance

Intervention: Anastrazole (Drug); Testosterone (Drug); Dutasteride (Drug); GnRH antagonist (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Official(s) and/or principal investigator(s):
Karen L Herbst, PhD, MD, Principal Investigator, Affiliation: University of California, San Diego

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.

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: insulin sensitivity

Secondary outcome:

body composition

lipid profile

Minimum age: 24 Years. Maximum age: 51 Years. Gender(s): Male.

Criteria:

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

University of California, San Diego, San Diego, California 92103, United States

VA San Diego Healthcare System, San Diego, California 92161, United States

Related publications:

Mårin P, Holmäng S, Gustafsson C, Jönsson L, Kvist H, Elander A, Eldh J, Sjöström L, Holm G, Björntorp P. Androgen treatment of abdominally obese men. Obes Res. 1993 Jul;1(4):245-51.

Mårin P, Holmäng S, Jönsson L, Sjöström L, Kvist H, Holm G, Lindstedt G, Björntorp P. The effects of testosterone treatment on body composition and metabolism in middle-aged obese men. Int J Obes Relat Metab Disord. 1992 Dec;16(12):991-7.

DeFronzo RA, Tobin JD, Andres R. Glucose clamp technique: a method for quantifying insulin secretion and resistance. Am J Physiol. 1979 Sep;237(3):E214-23.

Kapoor D, Goodwin E, Channer KS, Jones TH. Testosterone replacement therapy improves insulin resistance, glycaemic control, visceral adiposity and hypercholesterolaemia in hypogonadal men with type 2 diabetes. Eur J Endocrinol. 2006 Jun;154(6):899-906.

Starting date: June 2005
Last updated: March 15, 2011