Status:
RECRUITING
Cardiometabolic Benefit of Reducing Iatrogenic Hyperinsulinemia Using Insulin Adjunctive Therapy in Type 1 Diabetes
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Type 1 Diabetes Mellitus
Glucokinase-Maturity Onset Diabetes of the Young (GCK-MODY)
Eligibility:
All Genders
18-60 years
Phase:
EARLY_PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT06609356
Start Date
July 3 2025
End Date
December 1 2027
Last Update
December 23 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232