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NCT06609356 · ClinicalTrials.gov registry record · Early Phase 1

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

A Early Phase 1 study of Healthy Volunteer and Type 1 Diabetes Mellitus, sponsored by Vanderbilt University Medical Center.

Recruiting
Registry status
Early Phase 1
Development phase
27
Enrollment target
1
Study location

NCT06609356 is a Early Phase 1 study of Healthy Volunteer and Type 1 Diabetes Mellitus that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 27 participants, below the 202-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06609356, a Early Phase 1 study of Healthy Volunteer and Type 1 Diabetes Mellitus, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.

RECRUITING
Registry status
Early Phase 1
Development phase
27 participants
Enrollment target
1
Study location

Study Summary

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

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

Study Locations (1)

Tennessee

  • Vanderbilt University Medical Center - Nashville

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2025-07-03
Est. Completion 2027-12
Phase Early Phase 1

What the Registry Record Tells You About NCT06609356

The ClinicalTrials.gov registry entry for NCT06609356 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 202-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (87% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Healthy Volunteer appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT06609356 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.

Frequently Asked Questions

What is clinical trial NCT06609356 about?

NCT06609356 is a clinical study titled "Cardiometabolic Benefit of Reducing Iatrogenic Hyperinsulinemia Using Insulin Adjunctive Therapy in Type 1 Diabetes". 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...

What is the current status of trial NCT06609356?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 27 participants. The study started on 2025-07-03. Estimated completion is 2027-12.

What conditions does trial NCT06609356 study?

This clinical trial studies the following conditions: Healthy Volunteer, Type 1 Diabetes Mellitus, Glucokinase-Maturity Onset Diabetes of the Young (GCK-MODY), MODY2 Diabetes.

What interventions are being tested in trial NCT06609356?

The interventions under investigation include: Placebo (DRUG), Study Visit 1 (PROCEDURE), Study Visit 2 (PROCEDURE), Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor (DRUG).

Who is sponsoring clinical trial NCT06609356?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06609356 being conducted?

This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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