Actively Recruiting
Cardiometabolic Benefit of Reducing Iatrogenic Hyperinsulinemia Using Insulin Adjunctive Therapy in Type 1 Diabetes
Led by Vanderbilt University Medical Center · Updated on 2025-12-23
27
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Cardiometabolic Benefit of Reducing Iatrogenic Hyperinsulinemia Using Insulin Adjunctive Therapy in Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 60 years
- Body mass index (BMI) between 18 and 28 kg/m8
- Weight of at least 50 kg
- For type 1 diabetes participants: diabetes duration between 1 and 30 years
- HbA1c between 5.7% and 7.5% for type 1 diabetes and GCK-MODY participants
- Use of automated insulin delivery for type 1 diabetes participants
- Genetic confirmation of GCK mutation for GCK-MODY participants
- HbA1c less than 5.5% for healthy control participants
You will not qualify if you...
- One or more episodes of severe hypoglycemia in the past 3 months
- Any hospital admission for diabetic ketoacidosis in the past 6 months
- Systolic blood pressure greater than 140 mmHg and diastolic blood pressure greater than 100 mmHg
- Estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m8
- Liver enzymes (AST or ALT) greater than 2.5 times the upper limit of normal
- Hematocrit less than 35%
- Use of antioxidant vitamin supplements within 2 weeks before the study
- Use of systemic glucocorticoids
- Use of antipsychotic medications
- Use of beta blockers such as atenolol, metoprolol, or propranolol
- Use of niacin or thiazide diuretics
- Use of oral contraceptive pills with more than 35 mcg ethinyl estradiol
- Use of growth hormone, immunosuppressants, antihypertensives, or antihyperlipidemics
- Pregnancy
- Tanner stage less than 5
- Peri- or post-menopausal women
- Active smoking
- For type 1 diabetes participants: use of any diabetes medication other than insulin
- For type 1 diabetes participants: fasting C-peptide level greater than 0.7 ng/mL
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
D
Daniel J Moore, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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