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

What this study is testing ClinicalTrials.gov NCT07202247 ↗

Description as written by the study sponsor.

This phase II trial compares the effect of time-restricted eating (TRE) and glucagon-like peptide-1 (GLP1) receptor agonists (RA), semaglutide and tirzepatide, to an American Heart Association (AHA) heart healthy diet (HHD) intervention on heart and blood vessel health (cardiovascular system) and how the body processes food for energy (metabolic system) in prostate cancer patients undergoing androgen deprivation therapy (ADT). Prostate cancer patients who are receiving hormonal therapy (ADT) are at an increased risk of cardiovascular disease. This is thought to be due to treatment-related metabolic changes which may result in increased weight, body fat, insulin resistance and an increased risk of heart attack, stroke or other heart and blood vessel problems. TRE (also known as intermittent fasting) is an eating plan that alternates between fasting and non-fasting periods. This approach limits calorie intake to a specific window of time each day. GLP1-RAs, semaglutide and tirzepatide are in a class of medications called incretin mimetics. They work by helping the pancreas to release the right amount of insulin when blood sugar levels are high. Insulin helps move sugar from the blood into other body tissues where it is used for energy. They also slow the movement of food through the stomach and may decrease appetite and cause weight loss. The AHA HHD guidelines may be an effective method to help people learn about following a heart healthy eating plan. This may lower their risk of cardiovascular disease. Metabolic interventions, TRE and GLP1-RA, may be more effective than an AHA HHD intervention alone in improving cardiovascular and metabolic health in prostate cancer patients undergoing ADT.

Treatments tested

• Antiandrogen Therapy also known as ADT, Androgen Deprivation Therapy, Androgen Deprivation Therapy (ADT), Anti-androgen Therapy, Anti-androgen Treatment, Antiandrogen Treatment, Hormone Deprivation Therapy, Hormone-Deprivation Therapy Drug

  Given ADT

• Behavioral Intervention also known as Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments Behavioral

  Receive fasting reminders via Oncpatient Companion Mobile Application

• Biospecimen Collection also known as Biological Sample Collection, Biospecimen Collected, Specimen Collection Procedure

  Undergo blood sample collection

• Cardiac Computerized Tomographic Angiography Procedure

  Undergo a coronary computerized tomography angiography

• Computed Tomography also known as CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography Procedure

  Undergo CT

• Electronic Health Record Review Other

  Ancillary studies

• Internet-Based Intervention Other

  Complete survey and food diary collection via Oncpatient Companion Mobile Application

• Lifestyle Counseling Behavioral

  Receive diet and lifestyle counseling

• Medical Device Usage and Evaluation Other

  Wear an activity tracker

• Nutritional Intervention Other

  Receive AHA HHD guidelines

• Nutritional Intervention Other

  Receive AHA Life Essential 8 recommendations with personalized caloric intake

• Questionnaire Administration Other

  Ancillary studies

• Radiation Therapy also known as Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation Radiation

  Undergo RT

• Referral also known as Referred Other

  Receive a referral to an endocrinologist

• Semaglutide also known as Ozempic, Rybelsus, Wegovy Drug

  Given SC

• Short-Term Fasting also known as Intermittent Fasting, Short-term Intermittent Fasting Other

  Participate in an overnight fast

• Tirzepatide Drug

  Given SC