Pioglitazone and Insulin Resistance in ADT

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: State University of New York at Buffalo
• Treatments: Pioglitazone

Criteria

Inclusion Criteria:

1. Male, age ≥18 years of age.

2. Body Mass Index of > 25 kg/m2

3. 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

5. Hemoglobin > 11 g/dL, Creatinine < 1.5x ULN and liver function tests < 2x ULN 6. Participant must be able to read, write, and understand the English language and be able to provide written consent 7. Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

1. Known clinically significant severe COPD, ischemic heart disease, congestive heart failure, and/or significant cardiac arrhythmias

2. Any patient with known diabetes (A1c > 6.4%) or an anti-diabetic drug

3. Any condition contraindicating additional blood collection beyond standard of care

4. Subjects with known allergy to lidocaine (this is used to anesthetize area for fat biopsy)

5. Subjects with known allergy to pioglitazone or other thiazolidinediones

6. Subjects with pioglitazone use in last 6 months

7. Subjects with congestive Heart Failure Class 3 or 4

8. Subjects with osteoporosis, including history of fragility fracture

9. Subjects with history of bladder cancer

10. Subjects on chronic use of androgens, or opiates in the last 6 months or with panhypopituitarism, congenital HH (hypogonadotropic hypogonadism), prolactinoma, head trauma

11. Unwilling or unable to follow protocol requirements

12. Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to undergo study procedures.