Cardiometabolic Benefit of Reducing Iatrogenic Hyperinsulinemia Using Insulin Adjunctive Therapy in Type 1 Diabetes

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Sep 20, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to see how a specific treatment can help improve heart and blood sugar health in people with type 1 diabetes. The study will involve participants with type 1 diabetes, a rare type of diabetes called Glucokinase-Maturity Onset Diabetes of the Young (GCK-MODY), and healthy volunteers. The researchers will use a medication called an SGLT2 inhibitor, which helps the body remove excess sugar, with the aim of lowering high insulin levels that can be harmful. They believe that reducing these high insulin levels may lead to better overall health, including improved heart function and better blood sugar control.

To participate in the study, individuals must be between 18 and 60 years old and meet certain health criteria. For those with type 1 diabetes, they should have been diagnosed for 1 to 30 years and be using an automated insulin delivery system. Participants will undergo tests to compare their heart and blood sugar health under different conditions. The study is not yet recruiting, but if you're interested or think you might qualify, it’s a good idea to talk to your healthcare provider for more information about this trial.

Gender

ALL

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:
• • 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