RECRUITING

Prevention of Progression of Prediabetes, Obesity and CV Risk

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Conditions

Pre-DiabetesWeight, BodyCardiovascular DiseasesAffordable strategiesPrevention of progressionHispanic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The investigators are studying how to help people with prediabetes (Pre-DM) and obesity. The goal is to use new and affordable treatments to bring blood sugar levels back to normal and help participants to lose weight. The investigators also want to reduce participants risk of heart problems. The study team will look at how these treatments affect metabolism and other body functions to help find new ways to treat diabetes and obesity in the future.

Official Title

Pioneering and Affordable Strategies to Prevent Progression of Prediabetes, Obesity and CV Risk in Hispanics

Quick Facts

Study Start:2024-09-11
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06446531

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients will have an established diagnosis of pre-Diabetes Mellitus (DM) before the screening visit, documented by an acceptable modality in the last 6 months.
  2. 2. Age ≥ 18 years old
  3. 3. Body Mass Index (BMI)=25-40 kg/m2
  4. 4. Glycated Hemoglobin (HbA1c) = 5.7-6.4%
  5. 5. Blood Pressure (BP) \<160/100
  6. 6. Estimated Glomerular Filtration Rate (eGFR) ≥30 ml/min•1.73m2
  7. 7. Body weight must be stable (±5 pounds) over the last 3 months.
  8. 8. Oral diuretics, if prescribed to the patient according to local guidelines and discretion of the investigator, should be stable for at least 1 week prior to randomization.
  9. 9. Hispanic ethic group
  10. 10. Willing to adhere to medication regimen for up to 6 months.
  11. 11. Male or female, if female, met these criteria:
  12. 1. Not pregnant or breast-feeding
  13. 2. Negative pregnancy test result at visit 1 (screening)
  14. 3. During the entire study, women of childbearing potential (WOCBP) including peri-menopausal women who have a menstrual period within 1 year must practice appropriate, and effective birth control, either implants or pills, or a vasectomized partner prior to receiving the first dose of study medication
  15. 12. Does not suffer from severe claustrophobia
  16. 13. No contraindication for Magnetic Resonance Imaging (MRI) (metal plates, screws, shrapnel, pins, or cardiac pacemaker)
  1. 1. Patients currently on one of the selected therapies
  2. 2. Extended diagnoses with Type 2 Diabetes
  3. 3. Pregnancy, lactation, women of childbearing age (WOCBA) unwilling to use contraception
  4. 4. Known allergy/sensitivity to study drugs or their ingredients
  5. 5. Major oncologic diagnosis in the last 5 years
  6. 6. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
  7. 7. Inability or unwillingness of individual or legal guardian/representative to give written informed consent
  8. 8. Major organ or metabolic diseases, or physical limitations that will not allow the subject to complete the study
  9. 9. Myocardial infraction, coronary artery bypass graft surgery, or other major cardiovascular event in the past 60 days
  10. 10. Heart transplant recipient or listed for a heart transplant
  11. 11. Currently implanted left ventricular assist device
  12. 12. Cardiomyopathy based on infiltrative or cumulative hypertrophic obstructive cardiomyopathy or known pericardial constriction
  13. 13. Any severe (obstructive or regurgitant) valvular heart disease, expected to lead to surgery during the trial period
  14. 14. Acute decompensated heart failure requiring intravenous diuretics, vasodilators, inotropic agents, or mechanical support within 1 week of screening and during the screening period prior to randomization
  15. 15. Implanted cardioverter defibrillator within 3 months prior to screening
  16. 16. Cardiac resynchronization therapy

Contacts and Locations

Study Contact

Carolina Solis-Herrera, MD
CONTACT
210-567-4900
solisherrera@uthscsa.edu
Francisca Acosta, PhD
CONTACT
acostafm@uthscsa.edu

Principal Investigator

Carolina Solis-Herrera, MD
PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center at San Antonio

Study Locations (Sites)

University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center at San Antonio

  • Carolina Solis-Herrera, MD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center at San Antonio

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 Registration Dates

Study Start Date2024-09-11
Study Completion Date2027-07

Study Record Updates

Study Start Date2024-09-11
Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

  • Affordable strategies
  • Prevention of progression
  • Hispanic

Additional Relevant MeSH Terms

  • Pre-Diabetes
  • Weight, Body
  • Cardiovascular Diseases