Medication to Lower Insulin Levels in Type 1 Diabetes
Cardiometabolic Benefit of Reducing Iatrogenic Hyperinsulinemia Using Insulin Adjunctive Therapy in Type 1 Diabetes
Recruiting
Early Phase 1
Interventional Study
Type 1 Diabetes Mellitus
Glucokinase-Maturity Onset Diabetes of the Young (GCK-MODY)
MODY2 Diabetes
Healthy Volunteer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 60
- Sex
- Any
- Trial phase
- Early Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 27 (estimated)
- Sponsor
- Vanderbilt University Medical Center · Other
Who this trial is looking for
This trial is looking for people with type 1 diabetes or a specific type called GCK-MODY, as well as healthy volunteers. Participants will take a medication that helps lower insulin levels to study its effects on heart and blood sugar health.
Are You a Good Fit for This Trial?
You may be able to join if
- I am between 18 and 60 years old
- I weigh at least 50 kg
- I have type 1 diabetes for 1 to 30 years
- My HbA1c is between 5.7% and 7.5%
- I use automated insulin delivery
- I have been genetically confirmed to have GCK-MODY with an HbA1c between 5.7% and 7.5%
- My HbA1c is less than 5.5% if I am a healthy volunteer
You may not be able to join if
- I have had severe low blood sugar in the past 3 months
- I was hospitalized for diabetic ketoacidosis in the past 6 months
- My blood pressure is higher than 140/100 mmHg
- My kidneys do not function well (eGFR less than 60 mL/min/1.73 m²)
- My liver enzymes are high (more than 2.5 times the normal limit)
- My hematocrit is less than 35%
- I am pregnant
- I smoke tobacco
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Check Your Eligibility
About This Trial
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 medica…
Trial Locations
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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:
Hb…
Contacts