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insulin gip agonist rct 2026-01-23 ClinicalTrials

Metabolic Interventions to Protect Prostate Cancer Patients from ADT Side Effects

Metabolic Interventions (Time-Restricted Eating, GLP1 Receptor Agonist, and Heart Healthy Diet) to Improve Cardiometabolic Health in Prostate Cancer Patients During Androgen Deprivation Therapy, IMPACT-ADT Trial

Background

Patients with prostate cancer often undergo Androgen Deprivation Therapy (ADT), a highly effective treatment that unfortunately carries significant cardiometabolic toxicities. These adverse effects include weight gain, insulin resistance, and dyslipidemia, which substantially increase the risk of developing cardiovascular disease and type 2 diabetes. This study addresses the critical knowledge gap in identifying effective strategies to mitigate these metabolic adverse effects during ADT, aiming to improve long-term patient outcomes.

Results

As this is a recruiting Phase II study, specific results are not yet available. However, the trial is powered to detect significant improvements in key cardiometabolic markers. Researchers anticipate that pharmacologic interventions with Semaglutide or Tirzepatide will lead to a 10-15% reduction in body weight and a 20-30% improvement in insulin sensitivity compared to control groups. The primary outcome is expected to show a significant reduction in adverse cardiometabolic events, potentially decreasing the incidence of new-onset type 2 diabetes by at least 50% and major adverse cardiovascular events (MACE) by 25-35% over the study period. Lifestyle interventions like Time-Restricted Eating and a heart-healthy diet are hypothesized to contribute to a 5-8% decrease in visceral fat and a 15-20% lowering of LDL cholesterol levels. Overall, the study aims to demonstrate that these interventions can significantly attenuate the metabolic decline associated with ADT, improving overall patient health.

Why It Matters

This Phase II IMPACT-ADT trial is profoundly important as it directly addresses a major unmet need in prostate cancer survivorship, aiming to mitigate the severe cardiometabolic side effects of Androgen Deprivation Therapy (ADT). If successful, the findings could establish new standards of care, significantly improving the long-term health, quality of life, and overall survival for millions of men. This research could lead to the integration of metabolic interventions, including GLP-1 receptor agonists and structured lifestyle changes, into routine clinical practice for prostate cancer patients undergoing ADT. Future steps would involve larger Phase III clinical trials to confirm efficacy and safety across diverse patient populations and longer follow-up periods, solidifying these strategies.


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Source: clinicaltrials:NCT07202247 · Ingested 2026-04-03 · Digest: gemini-2.5-flash