RECRUITING

Cardiometabolic Benefit of Reducing Iatrogenic Hyperinsulinemia Using Insulin Adjunctive Therapy in Type 1 Diabetes

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

This study aims to understand the heart and blood sugar health benefits of using an adjunctive therapy to lower high insulin levels in people with type 1 diabetes. The investigators will also look at people with a specific type of diabetes called Glucokinase-Maturity Onset Diabetes of the Young (GCK-MODY) and those without diabetes to help interpret the results. The investigators will use a medication that helps the body get rid of sugar, called and SGLT2 inhibitor, with the goal to reduce the body's insulin requirements. The investigators believe this could lead to better heart and blood sugar health, including a better response to insulin and more available nitric oxide, a gas that helps blood vessels function well. The investigators will compare heart and blood sugar health risk factors in participants with type 1 diabetes, participants with Glucokinase-Maturity Onset Diabetes of the Young (GCK-MODY), and non-diabetic healthy volunteers under two conditions: high insulin levels typical of type 1 diabetes and normal insulin levels typical of the other two groups.

Official Title

Cardiometabolic Benefit of Reducing Iatrogenic Hyperinsulinemia Using Insulin Adjunctive Therapy in Type 1 Diabetes

Quick Facts

Study Start:2025-07
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06609356

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 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Any hospital admissions for diabetic ketoacidosis in the past 6 months
  2. * SBP greater than 140 mmHg and DBP greater than 100 mmHg
  3. * eGFR by MDRD equation of less than 60 mL/min/1.73 m²
  4. * AST or ALT greater than 2.5 times ULN
  5. * Hct less than 35%
  6. * Any antioxidant vitamin supplement within 2 weeks before the study
  7. * Any systemic glucocorticoid
  8. * Antipsychotics
  9. * Atenolol, Metoprolol, Propranolol
  10. * Niacin
  11. * Any thiazide diuretic
  12. * Any oral contraceptive pill with greater than 35 mcg ethinyl estradiol
  13. * Growth hormone
  14. * Any immunosuppressant
  15. * Antihypertensive
  16. * Any antihyperlipidemic
  17. * Pregnancy
  18. * Tanner stage less than 5
  19. * Peri- or post-menopausal women
  20. * Active smoker

Contacts and Locations

Study Locations (Sites)

Vanderbilt University medical Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical 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 Registration Dates

Study Start Date2025-07
Study Completion Date2027-12

Study Record Updates

Study Start Date2025-07
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • type 1 diabetes mellitus
  • with Glucokinase-Maturity Onset Diabetes of the Young (GCK-MODY)
  • nitric oxide
  • sodium-glucose cotransporter-2 inhibitors (SGLT2i)
  • healthy volunteer
  • insulin sensitivity
  • flow-mediated vasodilation (FMD)

Additional Relevant MeSH Terms

  • Type 1 Diabetes Mellitus
  • Glucokinase-Maturity Onset Diabetes of the Young (GCK-MODY)
  • MODY2 Diabetes
  • Healthy Volunteer