Metabolic Effects of Steroids in Obese Men

NCT00983554 | Unknown DMC

• 1 other identifier: DK65038 (completed)
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity; Insulin Resistance

Keywords

testosterone; insulin; obesity; aromatase; 5 alpha reductase

Outcome Measures

Primary Outcomes (1)

• insulin sensitivity

  14 weeks

Secondary Outcomes (2)

• body composition

  14 weeks

• lipid profile

  14 weeks

Study Arms (4)

Placebo

NO INTERVENTION

Anastrazole and Testosterone

EXPERIMENTAL

Drug: Anastrazole; Drug: Testosterone; Drug: Dutasteride; Drug: GnRH antagonist

Dutasteride and Testosterone

EXPERIMENTAL

Drug: Testosterone; Drug: Dutasteride; Drug: GnRH antagonist

Testosterone

EXPERIMENTAL

Drug: Testosterone; Drug: Dutasteride; Drug: GnRH antagonist

Interventions

Anastrazole DRUG

Arimidex 1mg daily

Anastrazole and Testosterone

Testosterone DRUG

Testim 10g daily

Anastrazole and Testosterone; Dutasteride and Testosterone; Testosterone

Dutasteride DRUG

Avodart 2.5mg daily

Anastrazole and Testosterone; Dutasteride and Testosterone; Testosterone

GnRH antagonist DRUG

Acyline 300 µg/kg subcutaneous injections every 2 weeks

Anastrazole and Testosterone; Dutasteride and Testosterone; Testosterone

Eligibility Criteria

• Age: 24 Years - 51 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• free T level in the lower 25% of the normal range or below
• BMI ≥30kg/m2
• waist circumference ≥100cm

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead
• University of California, San Diego: collaborator

Study Sites (2)

University of California, San Diego

San Diego, California, 92103, United States

Location

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

Related Publications (4)

• 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.

  PMID: 16350577 BACKGROUND

• 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.

  PMID: 1335979 BACKGROUND

• 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.

  PMID: 382871 BACKGROUND

• 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.

  PMID: 16728551 BACKGROUND

MeSH Terms

Conditions

Obesity; Insulin Resistance

Interventions

Anastrozole; Testosterone; Dutasteride; LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Azasteroids; Steroids, Heterocyclic

Study Officials

• Karen L Herbst, PhD, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 24, 2009
• Study Start: June 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: October 1, 2009
• Last Updated: March 16, 2011

Record last verified: 2011-03

Locations

US (2)