Study 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.
Eligible Conditions
- Insulin Resistance
- Obesity
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: 14 weeks
14 weeks
body composition
insulin sensitivity
lipid profile
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
Placebo
1 of 4
Anastrazole and Testosterone
1 of 4
Testosterone
1 of 4
Dutasteride and Testosterone
1 of 4
Active Control
Experimental Treatment
57 Total Participants · 4 Treatment Groups
Primary Treatment: Anastrazole and Testosterone · No Placebo Group · N/A
Anastrazole and TestosteroneExperimental Group · 4 Interventions: Anastrazole, Dutasteride, Testosterone, GnRH antagonist · Intervention Types: Drug, Drug, Drug, Drug
TestosteroneExperimental Group · 3 Interventions: Dutasteride, Testosterone, GnRH antagonist · Intervention Types: Drug, Drug, Drug
Dutasteride and TestosteroneExperimental Group · 3 Interventions: Dutasteride, Testosterone, GnRH antagonist · Intervention Types: Drug, Drug, Drug
PlaceboNoIntervention Group · 1 Intervention: Placebo · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anastrazole
2004
Completed Phase 4
~230
Dutasteride
FDA approved
Testosterone
FDA approved
Gonadorelin
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 14 weeks
Who is running the clinical trial?
University of California, San DiegoOTHER
1,029 Previous Clinical Trials
1,806,345 Total Patients Enrolled
3 Trials studying Insulin Resistance
122 Patients Enrolled for Insulin Resistance
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,148 Previous Clinical Trials
4,074,692 Total Patients Enrolled
74 Trials studying Insulin Resistance
11,616 Patients Enrolled for Insulin Resistance
Karen L Herbst, PhD, MDPrincipal InvestigatorUniversity of California, San Diego
2 Previous Clinical Trials
539 Total Patients Enrolled
Eligibility Criteria
Age 24 - 51 · Male Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| California | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
Why did patients apply to this trial?
- "I haven’t been able to gain any muscle since I was 15"
How many prior treatments have patients received?
| 0 | 100.0% |
References
- 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.
- Mårin P, Holmäng S, Jönsson L, Sjöström L, Kvist H, Holm G, Lindstedt G, Björntorp 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.
- Mårin P, Holmäng S, Gustafsson C, Jönsson L, Kvist H, Elander A, Eldh J, Sjöström L, Holm G, Björntorp P. Androgen treatment of abdominally obese men. Obes Res. 1993 Jul;1(4):245-51.
- DeFronzo, R A, J D Tobin, and R Andres. 1979. “Glucose Clamp Technique: A Method for Quantifying Insulin Secretion and Resistance.”. American Journal of Physiology-endocrinology and Metabolism. American Physiological Society. doi:10.1152/ajpendo.1979.237.3.e214.
- 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.
- 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.
- 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.
- 2005. "Metabolic Effects of Steroids in Obese Men". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00983554.
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