Pioglitazone and Insulin Resistance in ADT
NCT05098327 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2023-08-15
Summary
This study is being done to establish the mechanisms underlying insulin resistance (reduced insulin action that can lead to high blood sugar and maybe diabetes) in patients undergoing androgen deprivation therapy (ADT) for prostate carcinoma as well as to investigate the role of pioglitazone therapy in reduction/ reversal of that insulin resistance
Conditions
- Prostate Cancer
- Insulin Resistance
- Diabetes Mellitus, Type 2
- Androgen Deficiency
Interventions
- DRUG
-
Pioglitazone 30 mg
pioglitazone 30 mg dose 1 tab daily will be given for 12 weeks
- DRUG
-
placebo pills containing cellulose 1 pill daily will be given for 12 weeks
Sponsors & Collaborators
-
National Center for Advancing Translational Sciences (NCATS)
collaborator NIH -
State University of New York at Buffalo
lead OTHER
Principal Investigators
-
Paresh Dandona, MD, PhD · SUNY at Buffalo
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-08-01
- Primary Completion
- 2023-03-31
- Completion
- 2023-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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