Insulin Resistance and Androgen Deprivation Therapy

Saint Louis University (SLU)

Status and phase: Withdrawn; Phase 2

Conditions: Insulin Resistance; Prostate Cancer

Treatments: Drug: placebo tablet; Drug: Pioglitazone 30 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04995978

31991

Details and patient eligibility

About

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.

Full 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.

Sex: Male

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Pioglitazone

Experimental group

Treatment:

Drug: Pioglitazone 30 mg

placebo

Placebo Comparator group

Treatment:

Drug: placebo tablet