search
Back to results

Metabolic Effects of Steroids in Obese Men

Primary Purpose

Obesity, Insulin Resistance

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anastrazole
Testosterone
Dutasteride
GnRH antagonist
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring testosterone, insulin, obesity, aromatase, 5 alpha reductase

Eligibility Criteria

24 Years - 51 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of California, San Diego
  • VA San Diego Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Placebo

Anastrazole and Testosterone

Dutasteride and Testosterone

Testosterone

Arm Description

Outcomes

Primary Outcome Measures

insulin sensitivity

Secondary Outcome Measures

body composition
lipid profile

Full Information

First Posted
September 22, 2009
Last Updated
March 15, 2011
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
University of California, San Diego
search

1. Study Identification

Unique Protocol Identification Number
NCT00983554
Brief Title
Metabolic Effects of Steroids in Obese Men
Official Title
Metabolic Effects of Testosterone Alone or in Combination With Dutasteride or Anastrazole in Obese Men
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
October 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
University of California, San Diego

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Insulin Resistance
Keywords
testosterone, insulin, obesity, aromatase, 5 alpha reductase

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
No Intervention
Arm Title
Anastrazole and Testosterone
Arm Type
Experimental
Arm Title
Dutasteride and Testosterone
Arm Type
Experimental
Arm Title
Testosterone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Anastrazole
Intervention Description
Arimidex 1mg daily
Intervention Type
Drug
Intervention Name(s)
Testosterone
Intervention Description
Testim 10g daily
Intervention Type
Drug
Intervention Name(s)
Dutasteride
Intervention Description
Avodart 2.5mg daily
Intervention Type
Drug
Intervention Name(s)
GnRH antagonist
Intervention Description
Acyline 300 µg/kg subcutaneous injections every 2 weeks
Primary Outcome Measure Information:
Title
insulin sensitivity
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
body composition
Time Frame
14 weeks
Title
lipid profile
Time Frame
14 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen L Herbst, PhD, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
VA San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16350577
Citation
Marin P, Holmang S, Gustafsson C, Jonsson L, Kvist H, Elander A, Eldh J, Sjostrom L, Holm G, Bjorntorp P. Androgen treatment of abdominally obese men. Obes Res. 1993 Jul;1(4):245-51. doi: 10.1002/j.1550-8528.1993.tb00618.x.
Results Reference
background
PubMed Identifier
1335979
Citation
Marin P, Holmang S, Jonsson L, Sjostrom L, Kvist H, Holm G, Lindstedt G, Bjorntorp 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.
Results Reference
background
PubMed Identifier
382871
Citation
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. doi: 10.1152/ajpendo.1979.237.3.E214.
Results Reference
background
PubMed Identifier
16728551
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. doi: 10.1530/eje.1.02166.
Results Reference
background

Learn more about this trial

Metabolic Effects of Steroids in Obese Men

We'll reach out to this number within 24 hrs