Anastrazole and Testosterone for Insulin Resistance

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Insulin Resistance+1 MoreAnastrazole - Drug
Eligibility
24 - 51
Male
What conditions do you have?
Select

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

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 14 weeks

14 weeks
body composition
insulin sensitivity
lipid profile

Trial Safety

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

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Who else is applying?

What state do they live in?
California100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
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?
0100.0%
References