Insulin Resistance and Androgen Deprivation Therapy

NCT04995978 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 31991
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• insulin sensitivity

  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.

  6 months

Secondary Outcomes (1)

• Insulin signaling (Insulin receptor substrate expression in fat tissue)

  6 months

Study Arms (2)

Pioglitazone

EXPERIMENTAL

Drug: Pioglitazone 30 mg

placebo

PLACEBO COMPARATOR

Drug: placebo tablet

Interventions

Pioglitazone 30 mg DRUG

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.

Pioglitazone

placebo tablet DRUG

Subjects will self-administer an oral placebo tablet containing cellulose daily for 6 months.

placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Saint Louis Univeristy

St Louis, Missouri, 63104, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Insulin Resistance

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 9, 2021
• Study Start: December 1, 2021
• Primary Completion: January 18, 2023
• Study Completion: January 18, 2023
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)