Reducing high insulin levels to improve heart and blood sugar health in type 1 diabetes
Cardiometabolic Benefit of Reducing Iatrogenic Hyperinsulinemia Using Insulin Adjunctive Therapy in Type 1 Diabetes
This study is testing whether a new medication can help people with type 1 diabetes lower their insulin levels to improve their heart and blood sugar health.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT06609356 on ClinicalTrials.gov |
What this trial studies
This study investigates the cardiometabolic benefits of using an adjunctive therapy to lower iatrogenic hyperinsulinemia in individuals with type 1 diabetes. It also includes participants with Glucokinase-Maturity Onset Diabetes of the Young (GCK-MODY) and healthy volunteers to provide a comprehensive understanding of the effects. The intervention involves administering a sodium-glucose cotransporter-2 inhibitor to help reduce insulin requirements and improve heart and blood sugar health. The study aims to assess the impact on insulin response and nitric oxide availability, which are crucial for vascular function.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-60 with type 1 diabetes or GCK-MODY, who meet specific HbA1c and insulin therapy criteria.
Not a fit: Patients with severe hypoglycemia, significant comorbidities, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved heart and blood sugar health for patients with type 1 diabetes.
How similar studies have performed: Other studies have shown promise in using SGLT2 inhibitors for diabetes management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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: HbA1c: less than 5.5% \*\* Exclusion Criteria: 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
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Daniel J Moore, MD, PhD — Vanderbilt University Medical Center
- Study coordinator: Daniel J Moore, MD, PhD
- Email: metabolism@vumc.org
- Phone: 615-322-7427
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.