The Neuroendocrine Effects of Pioglitazone in Patients With Cancer and Cachexia (TRACE-1)

July 1, 2025 updated by: Steven Heymsfield, Pennington Biomedical Research Center

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Neuroendocrine Effects of Pioglitazone in Patients With Cancer and Cachexia

The goal of this clinical trial is evaluate the effect of pioglitazone compared with placebo on skeletal muscle insulin sensitivity in subjects with cancer and cachexia.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years
  • Documented histologic or cytologic diagnosis of non-small-cell lung cancer or gastrointestinal cancer that is locally advanced and inoperable or metastatic (e.g., spread to distant organs)
  • Cachexia defined by Fearon criteria
  • Insulin resistance syndrome, defined with the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
  • Ability to provide written informed consent, willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures
  • Provide written approval by a qualified healthcare professional
  • Allow the collection and storage of biospecimens and data for future use

Exclusion Criteria:

  • Prior diagnosis of type 2 diabetes
  • Prior or current thiazolidinedione (TZD) therapy
  • Known hypersensitivity to TZD
  • New York Heart Association (NYHA) class I-IV heart failure
  • History of or actively treated bladder cancer
  • Current use of CYP2C inhibitor (e.g., gemfibrozil) or CYP2C inducer (e.g., rifampin)
  • Inadequate hepatic function
  • Currently pregnant, breastfeeding, or planning to become pregnant within the next 16 weeks
  • Contraindications to magnetic resonance imaging (e.g., implanted cardiac device, cochlear implant)
  • Any other condition that, in the investigator's opinion, would preclude participation or successful compliance with the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo will have the same appearance as the active drug.
Experimental: Pioglitazone
Drug: Pioglitazone 45 mg
The dose of pioglitazone will not exceed 45 mg once daily. Pioglitazone dose will titrate progressively over the first three weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in skeletal muscle insulin sensitivity
Time Frame: Baseline, Week 12
Quantified using hyperinsulinemic-euglycemic clamp
Baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2024

Primary Completion (Actual)

June 30, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

June 12, 2023

First Submitted That Met QC Criteria

June 22, 2023

First Posted (Actual)

June 26, 2023

Study Record Updates

Last Update Posted (Actual)

July 4, 2025

Last Update Submitted That Met QC Criteria

July 1, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBRC 2023-013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

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.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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