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Recruiting NCT06609356

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

Early Phase I Interventional Type 1 Diabetes Mellitus Glucokinase-Maturity Onset Diabetes of the Young (GCK-MODY) MODY2 Diabetes Healthy Volunteer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Study Visit 1, Placebo, Study Visit 2, Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor.
Who it may be relevant to
Registry conditions: Type 1 Diabetes Mellitus, Glucokinase-Maturity Onset Diabetes of the Young (GCK-MODY), MODY2 Diabetes, Healthy Volunteer. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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).

Primary outcome measures

  • Aim 1: Tissue glucose disposal (TGD) [Time frame: 8 hours]
  • Aim 2: Nitric Oxide (NO) bioavailability [Time frame: 8 hours]
Secondary outcome measures (2)
  • Secondary outcome for Aim 1: Differences in endogenous glucose production [Time frame: 8 hours]
  • Secondary outcome for Aim 2: Nitroglycerin mediated vasodilation of the brachial artery [Time frame: 8 hours]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Vanderbilt University Medical Center — Nashville

Identifiers

NCT: NCT06609356 · 240996

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗