Insulin Resistance and Androgen Deprivation Therapy

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Prostate Cancer, Insulin Resistance

In brief

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.

Key facts

Study ID

NCT04995978

Run by

St. Louis University

People needed

0

Starts

2021-12-01

Expected to finish

2023-01-18

Last updated by the study team

2023-06-23

Who can join

Age: 18 and older, up to 85. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Saint Louis Univeristy — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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