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Corticosteroid

Anastrazole and Testosterone for Insulin Resistance

N/A
Waitlist Available
Led By Karen L Herbst, PhD, MD
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 weeks
Awards & highlights

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
insulin sensitivity
Secondary outcome measures
body composition
lipid profile

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: TestosteroneExperimental Treatment3 Interventions
Group II: Dutasteride and TestosteroneExperimental Treatment3 Interventions
Group III: Anastrazole and TestosteroneExperimental Treatment4 Interventions
Group IV: PlaceboActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anastrazole
2009
Completed Phase 4
~270
Testosterone
FDA approved
Dutasteride
FDA approved
Gonadorelin
FDA approved

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,381 Previous Clinical Trials
4,315,045 Total Patients Enrolled
88 Trials studying Insulin Resistance
13,296 Patients Enrolled for Insulin Resistance
University of California, San DiegoOTHER
1,135 Previous Clinical Trials
1,551,187 Total Patients Enrolled
3 Trials studying Insulin Resistance
122 Patients Enrolled for Insulin Resistance
Karen L Herbst, PhD, MDPrincipal InvestigatorUniversity of California, San Diego
2 Previous Clinical Trials
539 Total Patients Enrolled
~3 spots leftby Jul 2025
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