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

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

July 3, 2025

Primary Completion Date

July 31, 2027

Study Completion Date

December 31, 2027

Conditions
Type 1 Diabetes MellitusGlucokinase-Maturity Onset Diabetes of the Young (GCK-MODY)MODY2 DiabetesHealthy Volunteer
Interventions
PROCEDURE

Study Visit 1

Hyperinsulinemic, euglycemic clamp and flow-mediated dilation (FMD) study. The study will randomize participants to first receive a five-hour intravenous insulin infusion to achieve normal plasma insulin concentrations (Eu-Ins) or higher plasma insulin concentrations (Hi-Ins)

DRUG

Placebo

"* T1DM participants in the Hi-Ins study will receive an oral placebo. During the Eu-Ins study they will receive an SGLT2i.~* CGK-MODY participants and healthy volunteers will receive placebo in both studies."

PROCEDURE

Study Visit 2

Hyperinsulinemic, euglycemic clamp and flow-mediated dilation (FMD) study. Insulin levels infused during the five-hour insulin infusion will be opposite of the first visit.

DRUG

Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor

Concurrent with starting the five-hour infusion, T1DM participants in the Eu-Ins study will receive an SGLT2i dose (empagliflozin 25 mg).

Trial Locations (1)

37232

RECRUITING

Vanderbilt University Medical Center, Nashville

All Listed Sponsors
lead

Vanderbilt University Medical Center

OTHER