Metabolic Effects of Steroids in Obese Men

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00983554
• Other study ID #: DK65038 (completed)
• Status: Active, not recruiting
• Phase: N/A
• First received: September 22, 2009
• Last updated: March 15, 2011
• Start date: June 2005
• Est. completion date: October 2009

Study information

• Verified date: March 2011
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 57
• Est. completion date: October 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 24 Years to 51 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

Intervention

Drug:
• Anastrazole
Arimidex 1mg daily
• Testosterone
Testim 10g daily
• Dutasteride
Avodart 2.5mg daily
• GnRH antagonist
Acyline 300 µg/kg subcutaneous injections every 2 weeks

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California
United States	VA San Diego Healthcare System	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin sensitivity		14 weeks	No
Secondary	body composition		14 weeks	No
Secondary	lipid profile		14 weeks	No