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Metabolic Effects of Steroids in Obese Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00983554
Recruitment Status : Unknown
Verified March 2011 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was:  Active, not recruiting
First Posted : September 24, 2009
Last Update Posted : March 16, 2011
Sponsor:
Collaborator:
University of California, San Diego
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Tracking Information
First Submitted Date  ICMJE September 22, 2009
First Posted Date  ICMJE September 24, 2009
Last Update Posted Date March 16, 2011
Study Start Date  ICMJE June 2005
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2009)
insulin sensitivity [ Time Frame: 14 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2009)
  • body composition [ Time Frame: 14 weeks ]
  • lipid profile [ Time Frame: 14 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metabolic Effects of Steroids in Obese Men
Official Title  ICMJE Metabolic Effects of Testosterone Alone or in Combination With Dutasteride or Anastrazole in Obese Men
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Insulin Resistance
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • No Intervention: Placebo
  • Experimental: Anastrazole and Testosterone
    Interventions:
    • Drug: Anastrazole
    • Drug: Testosterone
    • Drug: Dutasteride
    • Drug: GnRH antagonist
  • Experimental: Dutasteride and Testosterone
    Interventions:
    • Drug: Testosterone
    • Drug: Dutasteride
    • Drug: GnRH antagonist
  • Experimental: Testosterone
    Interventions:
    • Drug: Testosterone
    • Drug: Dutasteride
    • Drug: GnRH antagonist
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: September 22, 2009)
57
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 24 Years to 51 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00983554
Other Study ID Numbers  ICMJE DK65038 (completed)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Karen L. Herbst, University of California, San Diego
Study Sponsor  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators  ICMJE University of California, San Diego
Investigators  ICMJE
Principal Investigator: Karen L Herbst, PhD, MD University of California, San Diego
PRS Account National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP