Insulin Resistance and Androgen Deprivation Therapy

Sponsor
St. Louis University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04995978
Collaborator
(none)
44
1
2
73
0.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Pioglitazone 30 mg
  • Drug: placebo tablet
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Insulin Resistance in Men With Prostate Cancer on Androgen Deprivation Therapy
Actual Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2026
Anticipated Study Completion Date :
Dec 31, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pioglitazone

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.

Placebo Comparator: placebo

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

Outcome Measures

Primary Outcome Measures

  1. insulin sensitivity [6 months]

    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 Outcome Measures

  1. Insulin signaling (Insulin receptor substrate expression in fat tissue) [6 months]

    A secondary endpoint for the study will be comparison of the relative change from baseline in insulin signaling after pioglitazone or placebo.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Saint Louis Univeristy Saint Louis Missouri United States 63104

Sponsors and Collaborators

  • St. Louis University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sandeep Singh Dhindsa, M.D., F.A.C.E, Professor of Medicine, St. Louis University
ClinicalTrials.gov Identifier:
NCT04995978
Other Study ID Numbers:
  • 31991
First Posted:
Aug 9, 2021
Last Update Posted:
Jul 1, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 1, 2022