NCT04658849

Insulin Resistance Following ADT for Prostate CA

Withdrawn EARLY_PHASE1 Last updated 15 May 2023

What this trial tests

EARLY_PHASE1 trial testing Pioglitazone 30 Mg Oral Tablet in Insulin Resistance. Withdrawn.

Timeline

2 December 2020

Primary endpoint
29 March 2023

29 March 2023

Quick facts

Lead sponsor	St. Louis University
Phase	EARLY_PHASE1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Start date	2 December 2020
Primary completion	29 March 2023
Estimated completion	29 March 2023
Sites	1 location across United States

Drugs / interventions tested

• Pioglitazone 30 Mg Oral Tablet
• Pioglitazone placebo tablet

Conditions studied

• Insulin Resistance — all drugs for Insulin Resistance →
• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

St. Louis University

Who can join

Adults 18 to 85, male only, with Insulin Resistance or Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Prostate cancer is the most common cancer in men in the United States. Suppression of male hormone levels by using GnRH agonist ("hormone blocking therapy") for a few years is routinely used to treat prostate cancer. While the treatment is very effective, it decreases muscle mass and increases fat mass. This results in a decrease in insulin action (also called insulin resistance) and increases the likelihood of diabetes. It may also contribute to risk of developing heart disease. The investigators propose to conduct a trial that will:-

1. study the mechanisms through which GnRH agonists cause insulin resistance.
2. Evaluate a treatment that can decrease insulin resistance. This is a randomized, placebo controlled, double-blind trial. Forty-four men with prostate cancer will be recruited in the trial before starting GnRH agonist therapy. Participants will undergo metabolic studies to evaluate insulin action (called insulin clamp), abdominal fat tissue biopsy to study insulin action at the cellular level and blood draws. The study volunteers will then be given either a placebo tablet or pioglitazone tablet to take once a day for the next six months. The metabolic tests, blood test and fat tissue biopsy will be obtained again at the end of the study.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Repurposing non-oncology small-molecule drugs to improve cancer therapy: Current situation and future directions.
   Fu L, Jin W, Zhang J, Zhu L, et al · · 2022 · cited 47× · PMID 35256933 · DOI 10.1016/j.apsb.2021.09.006