NCT04995978

Insulin Resistance and Androgen Deprivation Therapy

Insulin Resistance in Men With Prostate Cancer on Androgen Deprivation Therapy

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: St. Louis University · Academic / Other
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Investigators plan to conduct a prospective, randomized, double-blind, placebo-controlled trial in 44 men with nonmetastatic prostate cancer who are receiving ADT with long acting GnRH agonist (study group). Study subjects will undergo insulin clamp, subcutaneous fat biopsy, muscle biopsy, have a blood sample taken and fibroscan performed prior to randomization of study drug. They will then be randomized to 30 mg pioglitazone or placebo tablet daily for 6 months. Blood samples will be drawn 2 and 4 months following the initiation of the study drug. The final study visit will be at 6 months. Subjects will undergo clamp, fat biopsy, muscle biopsy, blood sampling, fibroscan and will be discharged from the study.

Conditions

• Prostate Cancer
• Insulin Resistance

Interventions

Type	Name	Description
DRUG	Pioglitazone 30 mg	Subjects will self-administer a 30 mg pioglitazone oral tablet daily for 6 months. For patient taking a diabetic regimen of gemfibrozil, the dose will be 15 mg daily.
DRUG	placebo tablet	Subjects will self-administer an oral placebo tablet containing cellulose daily for 6 months.

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-01-18
• Completion: 2023-01-18
• First posted: 2021-08-09
• Last updated: 2023-06-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study