Clinical trial · Interventional
Insulin Resistance and Androgen Deprivation Therapy
Insulin Resistance in Men With Prostate Cancer on Androgen Deprivation Therapy
- 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 participants were recruited and the study was deemed not feasible
Summary
Brief summary (as posted)
Prostate cancer is the most common malignancy amongst men in United States. Androgen deprivation therapy (ADT) with long acting gonadotropin releasing hormone agonists is routinely used as adjuvant therapy in intermediate and high risk localized or locally advanced prostate cancer. Since ADT induces insulin resistance and diabetes, it is important that cellular and molecular effects of ADT are investigated to define precisely the mechanisms involved in the pathogenesis of insulin resistance. Pioglitazone, a known insulin sensitizer, may provide amelioration of insulin resistance in these patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| 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 tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pioglitazone
- interventionNames
- Drug: Pioglitazone 30 mg
- type
- PLACEBO_COMPARATOR
- label
- placebo
- interventionNames
- Drug: placebo tablet
Primary outcomes (1)
- measure
- insulin sensitivity
- timeFrame
- 6 months
- description
- The primary endpoint of the study is to detect a difference in insulin sensitivity as measured by whole body glucose uptake during clamps after treatment with pioglitazone as compared to placebo.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Prostate cancer, non-metastatic * Have been on ADT with long acting GnRH agonist continuously for last 3 months, AND planning to continue ADT for at least 6 months Exclusion Criteria: * Used pioglitazone in last 6 months * Heart Failure NYHA Class 3 or 4 * Known to have osteoporosis at this time. * history of bladder cancer * Hemoglobin \<8 g/dl * eGFR \<15 ml/min/1.73m2 * liver enzymes (ALT or AST) \>3 times the upper limit of normal
References
Publications (0)
Data not yet available