Clinical trial NCT00983554: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Insulin Resistance
Keywords: testosterone
insulin
obesity
aromatase
5 alpha reductase
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: University of California, San Diego
First posted: 2009-09-24
Enrollment: 57
Sex: MALE
Minimum age (years): 24
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: insulin sensitivity
timeFrame: 14 weeks
Secondary outcomes:
measure: body composition
timeFrame: 14 weeks
measure: lipid profile
timeFrame: 14 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
Study officials:
affiliation: University of California, San Diego
name: Karen L Herbst, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.