Metabolic Effects of Steroids in Obese Men

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of California, San Diego
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00983554
First received: September 22, 2009
Last updated: March 15, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Obesity
Insulin Resistance
Drug: Anastrazole
Drug: Testosterone
Drug: Dutasteride
Drug: GnRH antagonist

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Metabolic Effects of Testosterone Alone or in Combination With Dutasteride or Anastrazole in Obese Men

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • insulin sensitivity [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • body composition [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • lipid profile [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: June 2005
Estimated Study Completion Date: October 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Placebo
Experimental: Anastrazole and Testosterone 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
Experimental: Dutasteride and Testosterone Drug: Testosterone
Testim 10g daily
Drug: Dutasteride
Avodart 2.5mg daily
Drug: GnRH antagonist
Acyline 300 µg/kg subcutaneous injections every 2 weeks
Experimental: Testosterone Drug: Testosterone
Testim 10g daily
Drug: Dutasteride
Avodart 2.5mg daily
Drug: GnRH antagonist
Acyline 300 µg/kg subcutaneous injections every 2 weeks

  Eligibility

Ages Eligible for Study:   24 Years to 51 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00983554

Locations
United States, California
University of California, San Diego
San Diego, California, United States, 92103
VA San Diego Healthcare System
San Diego, California, United States, 92161
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Karen L Herbst, PhD, MD University of California, San Diego
  More Information

Publications:
Responsible Party: Karen L. Herbst, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00983554     History of Changes
Other Study ID Numbers: DK65038 (completed)
Study First Received: September 22, 2009
Last Updated: March 15, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
testosterone
insulin
obesity
aromatase
5 alpha reductase

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Anastrozole
Dutasteride
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
5-alpha Reductase Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014