Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
57 participants
INTERVENTIONAL
2005-06-30
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
No interventions assigned to this group
Anastrazole and Testosterone
Anastrazole
Arimidex 1mg daily
Testosterone
Testim 10g daily
Dutasteride
Avodart 2.5mg daily
GnRH antagonist
Acyline 300 µg/kg subcutaneous injections every 2 weeks
Dutasteride and Testosterone
Testosterone
Testim 10g daily
Dutasteride
Avodart 2.5mg daily
GnRH antagonist
Acyline 300 µg/kg subcutaneous injections every 2 weeks
Testosterone
Testosterone
Testim 10g daily
Dutasteride
Avodart 2.5mg daily
GnRH antagonist
Acyline 300 µg/kg subcutaneous injections every 2 weeks
Interventions
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Anastrazole
Arimidex 1mg daily
Testosterone
Testim 10g daily
Dutasteride
Avodart 2.5mg daily
GnRH antagonist
Acyline 300 µg/kg subcutaneous injections every 2 weeks
Eligibility Criteria
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Inclusion Criteria
* BMI ≥30kg/m2
* waist circumference ≥100cm
Exclusion Criteria
* 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
24 Years
51 Years
MALE
Yes
Sponsors
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University of California, San Diego
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Responsible Party
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University of California, San Diego
Principal Investigators
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Karen L Herbst, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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University of California, San Diego
San Diego, California, United States
VA San Diego Healthcare System
San Diego, California, United States
Countries
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References
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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.
Other Identifiers
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DK65038 (completed)
Identifier Type: -
Identifier Source: org_study_id
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