WithdrawnPhase 3

Pioglitazone and Insulin Resistance in ADT

Stopped: no participant enrolled due to lack of interest.

United States0Started 2021-08-01

Plain-language 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

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. Male, age ≥18 years of age.
✓. Body Mass Index of \> 25 kg/m2
✓. Biopsy-confirmed prostate adenocarcinoma currently on androgen deprivation therapy (ADT) for minimum of 3 months for the ADT group and biopsy-confirmed prostate adenocarcinoma not on ADT for control group

Exclusion criteria

✕. Known clinically significant severe COPD, ischemic heart disease, congestive heart failure, and/or significant cardiac arrhythmias
✕. Any patient with known diabetes (A1c \> 6.4%) or an anti-diabetic drug
✕. Any condition contraindicating additional blood collection beyond standard of care
✕. Subjects with known allergy to lidocaine (this is used to anesthetize area for fat biopsy)
✕. Subjects with known allergy to pioglitazone or other thiazolidinediones
✕. Subjects with pioglitazone use in last 6 months
✕. Subjects with congestive Heart Failure Class 3 or 4
✕. Subjects with osteoporosis, including history of fragility fracture

What they're measuring

HOMA-IR

Timeframe: 12 weeks

Trial details

NCT IDNCT05098327

SponsorState University of New York at Buffalo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-31

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