SGLT2 Inhibitor for Type 1 Diabetes

(ACT T1D Trial)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Vanderbilt University Medical Center

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for people with type 1 diabetes to explore the benefits of reducing high insulin levels using an SGLT2 inhibitor, a drug that helps eliminate sugar from the body. It also includes individuals with GCK-MODY and healthy subjects to compare results.

Inclusion Criteria

I weigh 50 kg or more.

My HbA1c levels are between 5.7% and 7.5%.

BMI: 18-28 kg/m²

Exclusion Criteria

My blood pressure is higher than 140/100 mmHg.

I have not been hospitalized for diabetic ketoacidosis in the last 6 months.

I am currently taking Niacin.

Treatment Details

Interventions

• Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor (SGLT2 Inhibitor)

Trial Overview The study tests if an SGLT2 inhibitor can improve heart health and blood sugar management in type 1 diabetics by lowering their need for insulin. Participants will be compared under conditions of high and normal insulin levels.

Participant Groups

Group I: High insulin Experimental Treatment 3 Interventions

Participants will receive a "high insulin infusion" (Hi-Ins) prior to quantifying insulin resistance and endothelial function. This infusion will result in participants having insulin levels similar to patients with type 1 diabetes for five hours.

Group II: Normal insulin Active Control 4 Interventions

Participants will receive a "normal insulin infusion" (Eu-Ins) prior to quantifying insulin resistance and endothelial function. This infusion will result in participants having insulin levels similar to people without diabetes and people with GCK-MODY for five hours.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+