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RecruitingAccepts healthy volunteersEarly Phase 1

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

Vanderbilt University Medical Center · NCT06609356

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–60 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Early Phase 1
Target enrollment
27
US sites recruiting
1
Study start
July 3, 2025
Record last updated
December 23, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Study Visit 1; Placebo; Study Visit 2; Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

Age: 18-60 years BMI: 18-28 kg/m² Weight: ≥ 50 kg

T1DM Participants:

Duration of T1DM: 1-30 years HbA1c: 5.7-7.5% Insulin Therapy: Using automated insulin delivery

GCK-MODY Participants

HbA1c: 5.7-7.5% Genetic Confirmation: Positive GCK sequencing

Control Participants

HbA1c: less than 5.5%

** Exclusion Criteria: Severe Hypoglycemia: ≥1 episode in the past 3 months

Comorbidities

  • 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%

Medications

  • 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

Other

  • Pregnancy
  • Tanner stage less than 5
  • Peri- or post-menopausal women
  • Active smoker

T1DM Participants:

Medications: Any diabetes medication except insulin C-peptide: greater than 0.7 ng/mL (fasting)

GCK-MODY Participants

None specific

Recruiting US locations

  • Vanderbilt University Medical Center

    Nashville, TN 37232

    Site contact: Daniel J Moore, MD, PhD · (615) 322- 7427 · metabolism@vumc.org

Study contacts (from the official record)

  • Daniel J Moore, MD, PhD · 615-322-7427 · metabolism@vumc.org
All diabetes studies in Tennessee →
Cardiometabolic Benefit of Reducing Iatrogenic Hyperinsulinemia… (NCT06609356) | Bored Studies