Back to resultsInsulin Resistance and Androgen Deprivation Therapy
Primary Purpose
Prostate Cancer, Insulin Resistance
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pioglitazone 30 mg
placebo tablet
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- Saint Louis Univeristy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Pioglitazone
placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Insulin signaling (Insulin receptor substrate expression in fat tissue)
A secondary endpoint for the study will be comparison of the relative change from baseline in insulin signaling after pioglitazone or placebo.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04995978
Brief Title
Insulin Resistance and Androgen Deprivation Therapy
Official Title
Insulin Resistance in Men With Prostate Cancer on Androgen Deprivation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Withdrawn
Why Stopped
No participants were recruited and the study was deemed not feasible
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
January 18, 2023 (Actual)
Study Completion Date
January 18, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Louis University
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Insulin Resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pioglitazone
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pioglitazone 30 mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo tablet
Intervention Description
Subjects will self-administer an oral placebo tablet containing cellulose daily for 6 months.
Primary Outcome Measure Information:
Title
insulin sensitivity
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Insulin signaling (Insulin receptor substrate expression in fat tissue)
Description
A secondary endpoint for the study will be comparison of the relative change from baseline in insulin signaling after pioglitazone or placebo.
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Saint Louis Univeristy
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Insulin Resistance and Androgen Deprivation Therapy
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