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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: Recruiting Early Phase 1 study of Healthy Volunteer and Type 1 Diabetes Mellitus, sponsored by Vanderbilt University Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary outcome will be the difference in tissue glucose disposal (TGD) during a hyperinsulinemic, euglycemic clamp between Eu-Ins and Hi-Ins studies.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2025-07-03 |
| Est. Completion | 2027-12 |
| Phase | Early Phase 1 |
What NCT06609356 shows while recruiting
NCT06609356 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 202-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (87% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT06609356's enrollment target sits among peer trials
27 80th of 112 higher than 31 of 112 other Healthy Volunteer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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