Metabolic Effects of Steroids in Obese Men

• ClinicalTrials.gov Identifier: NCT00983554
• Recruitment Status: Unknown
• First Posted: September 24, 2009
• Last Update Posted: March 16, 2011
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Collaborator: University of California, San Diego
• Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Condition or disease	Intervention/treatment	Phase
Obesity; Insulin Resistance	Drug: Anastrazole; Drug: Testosterone; Drug: Dutasteride; Drug: GnRH antagonist	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 57 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Metabolic Effects of Testosterone Alone or in Combination With Dutasteride or Anastrazole in Obese Men
• Study Start Date: June 2005
• Actual Primary Completion Date: May 2009
• Estimated Study Completion Date: October 2009

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. insulin sensitivity [ Time Frame: 14 weeks ]

Secondary Outcome Measures :

1. body composition [ Time Frame: 14 weeks ]
2. lipid profile [ Time Frame: 14 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 24 Years to 51 Years (Adult)
• Sexes 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

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

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

University of California, San Diego

Investigators

• Principal Investigator: Karen L Herbst, PhD, MD; University of California, San Diego

More Information

Publications:

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.

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.

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.

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.

• Responsible Party: Karen L. Herbst, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT00983554
• Other Study ID Numbers: DK65038 (completed)
• First Posted: September 24, 2009
• Last Update Posted: March 16, 2011
• Last Verified: March 2011

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; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Anastrozole; Testosterone; Dutasteride; Androgens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents; 5-alpha Reductase Inhibitors; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Hormone Antagonists; Aromatase Inhibitors; Estrogen Antagonists