Clinical trial · Interventional
Pioglitazone and Insulin Resistance in ADT
Role of Pioglitazone Therapy in Management of Insulin Resistance Associated With Androgen Deprivation Therapy (ADT) in Patients With Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): no participant enrolled due to lack of interest.
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Androgen Deficiency | — | UNRESOLVED | — |
| Diabetes Mellitus, Type 2 | — | UNRESOLVED | — |
| Insulin Resistance | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pioglitazone 30 mg | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Prostate cancer on ADT receiving pioglitazone
- description
- Subjects will receive a 12-week supply of pioglitazone 30 mg dose 1 tab daily
- interventionNames
- Drug: Pioglitazone 30 mg
- type
- PLACEBO_COMPARATOR
- label
- Prostate cancer on ADT receiving placebo
- description
- Subjects will receive a 12 week supply of placebo pills containing cellulose
- interventionNames
- Drug: Placebo
- type
- NO_INTERVENTION
- label
- Prostate cancer not on ADT
- description
- No intervention will be done in this group
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available