Cardiometabolic Benefits of Reducing High Insulin in Type 1 Diabetes

This study is looking at how reducing high insulin levels in people with type 1 diabetes might improve heart and blood sugar health. Researchers will use a medication called empagliflozin (an SGLT2 inhibitor) to help the body get rid of sugar and potentially lower insulin needs. They will compare this to a placebo. The study will also include people with a specific type of diabetes called GCK-MODY and healthy volunteers to help understand the results. The goal is to see if this approach can lead to better insulin response and improved blood vessel function. You might be able to join if you are 18-60 years old with type 1 diabetes, GCK-MODY, or are a healthy volunteer. The study is currently unclear on its recruitment status and plans to enroll 27 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It involves randomizing participants to different treatment sequences during two study visits.
What's involved
You would participate in two study visits, each involving a hyperinsulinemic, euglycemic clamp (a procedure to control blood sugar and insulin) and a flow-mediated dilation (FMD) study (to check blood vessel function).
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes, tissue glucose disposal and nitric oxide bioavailability, are measured at 8 hours after the start of the intervention.

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NCT06609356

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

Recruiting
EARLY_PHASE1Ages 18–60InterventionalTreatment
Vanderbilt University Medical Center
~27 participants
Updated 2025-12-23 on ClinicalTrials.gov
What's tested:Study Visit 1PlaceboStudy Visit 2Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Aim 1: Tissue glucose disposal (TGD)
Measured over 8 hours
+1 more outcome measured
Type 1 Diabetes Mellitus
Glucokinase-Maturity Onset Diabetes of the Young (GCK-MODY)
MODY2 Diabetes
Healthy Volunteer
1 sites across 1 states
Tennessee1
  • Daniel J Moore, MD, PhD · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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
Hct less than 35%
Any antioxidant vitamin supplement within 2 weeks before the study
Any systemic glucocorticoid
Antipsychotics
Atenolol, Metoprolol, Propranolol
Niacin
Any thiazide diuretic
Any oral contraceptive pill with greater than 35 mcg ethinyl estradiol
Growth hormone
Any immunosuppressant
Antihypertensive
Any antihyperlipidemic
Pregnancy
Tanner stage less than 5
Peri- or post-menopausal women
Active smoker
  • Aim 1: Tissue glucose disposal (TGD)8 hours

    The primary outcome will be the difference in tissue glucose disposal (TGD) during a hyperinsulinemic, euglycemic clamp between Eu-Ins and Hi-Ins studies.

  • Aim 2: Nitric Oxide (NO) bioavailability8 hours

    This study aims to determine the difference in hyperinsulinemia-mediated suppression of nitric oxide (NO) bioavailability between Eu-Ins and Hi-Ins studies, as measured by flow mediated dilation (FMD) of the brachial artery.