RECRUITING

Metformin and Vascular Function in Prediabetes

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 goal of this clinical trial is to investigate whether metformin improves vascular function in individuals with prediabetes. The main questions it aims to answer are: 1. Does metformin improve large conduit artery endothelial function in individuals with prediabetes? 2. Does metformin improve microvascular endothelial function in individuals with prediabetes? Researchers will compare metformin to a placebo to see if metformin improves vascular function in prediabetes. The trial duration is 12 weeks. Participants will take metformin or a placebo once a day for 2 weeks. After 2 weeks, participants will take metformin or a placebo twice a day for the remaining 10 weeks. There will be a screening visit, two baseline visits, a 4-week safety visit, and two 12-week end-of-study visits. Adherence will be calculated from pill count and adverse events will be quantified via a questionnaire.

Official Title

Metformin and Vascular Function in Prediabetes

Quick Facts

Study Start:2024-11-13
Study Completion:2026-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06526494

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 to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-55 years
  2. * Prediabetes defined as an HbA1c between 5.7% and 6.4%
  3. * Able to provide informed consent
  1. * Current use of metformin or metformin use within the past 12 months
  2. * Current use of medicated contraindicated for use with metformin
  3. * Current use of vitamin C supplement
  4. * Current smoker or quit smoking within the last 6 months
  5. * Pregnant, breastfeeding, planning to become pregnant, or unwilling to use adequate birth control
  6. * Uncontrolled hypertension (Systolic blood pressure \>140 mmHg)
  7. * Body Mass Index \> 40 kg/m2
  8. * History of diabetes, myocardial infarction, heart failure, liver disease, or chronic kidney disease (estimated glomerular filtration rate \< 45 ml/min/1.73m2)
  9. * History of lactic acidosis
  10. * History of alcohol abuse
  11. * Severe infection within the last 30 days
  12. * Immunosuppressive therapy within the past year
  13. * Life expectancy \< 1 year
  14. * Allergy to metformin, nitroglycerin, sodium nitroprusside, ringer's lactate
  15. * Study compliance: Unwilling to fast overnight, have an intravenous catheter placed, take a study drug for 12 weeks, or visit Iowa campus 6 times within a 12-16 week period

Contacts and Locations

Study Contact

Diana I Jalal, MD
CONTACT
319 338 0581
diana-jalal@uiowa.edu

Principal Investigator

Diana I Jalal, MD
PRINCIPAL_INVESTIGATOR
University of Iowa

Study Locations (Sites)

University of Iowa
Iowa City, Iowa, 52242
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52245
United States

Collaborators and Investigators

Sponsor: Diana Jalal

  • Diana I Jalal, MD, PRINCIPAL_INVESTIGATOR, University of Iowa

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 Date2024-11-13
Study Completion Date2026-10-01

Study Record Updates

Study Start Date2024-11-13
Study Completion Date2026-10-01

Terms related to this study

Keywords Provided by Researchers

  • vascular function
  • metformin
  • prediabetes

Additional Relevant MeSH Terms

  • PreDiabetes