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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorVanderbilt University Medical Center

About 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

Qualifiers

None

Disqualifiers

Any hospital admissions for diabetic ketoacidosis in the past 6 months

SBP greater than 140 mmHg and DBP greater than 100 mmHg

eGFR by MDRD equation of less than 60 mL/min/1.73 m²

AST or ALT greater than 2.5 times ULN

Trial design

Treatments tested in this trial

  • Study Visit 1
  • Placebo
  • Study Visit 2
  • Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor

Treatment groups

27 Participants
are divided into 2 treatment groups