MANATEE-T1D: Metformin ANd AutomaTEd Insulin Delivery System Effects on Renal Vascular Resistance, Insulin Sensitivity, and Cardiometabolic Function in Youth With Type 1 Diabetes (MANATEE-T1D)
Type 1 Diabetes, Diabetic Kidney Disease, Cardiovascular Diseases
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 diabetes, Youth, Insulin sensitivity, Cardiovascular function, Diabetic kidney disease
Eligibility Criteria
Inclusion Criteria:
- Youth with pancreatic antibody positive type 1 diabetes
- Age 12-21 years
- Use of an automated insulin delivery system or multiple daily insulin injections plus a continuous glucose monitor for > 6 months
- Pubertal
- Weight > 54 kg and BMI > 5th percentile for age and sex
- Hemoglobin A1c < 11%
- No recent episodes of diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome (HHS)
Exclusion Criteria:
- Blood pressure > 140/90 mm Hg
- Anemia
- Estimated glomerular filtration rate < 60 mL/min/1.73 m2 or serum creatinine > 1.2 mg/dL or history of urinary albumin to creatinine ratio ≥ 300mg/g or history of acute kidney injury
- Use of anti-diabetic agents except insulin, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB's), diuretics, daily non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin, sulfonamides, procaine, thiazosulfone or probenecid
- Seafood or iodine allergy
- Pregnancy or breast feeding for females
Sites / Locations
- University of Colorado Anschutz Medical CampusRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Placebo Comparator
Other
Metformin plus automated insulin delivery system
Placebo plus automated insulin delivery system
Multiple daily insulin injections plus continuous glucose monitor
Some participants with type 1 diabetes using an automated insulin delivery system will be randomized to receive treatment with metformin and will undergo RPF (Aminohippurate Sodium Injections 20%), GFR (Iohexol Inj 300 MG/ML), and insulin sensitivity (hyperinsulinemic-euglycemic clamp) assessments, in additional to assessments of cardiovascular and endothelial function.
Some participants with type 1 diabetes using an automated insulin delivery system will be randomized to receive treatment with a placebo pill which is identical in appearance to the metformin pill and will undergo RPF (Aminohippurate Sodium Injections 20%), GFR (Iohexol Inj 300 MG/ML), and insulin sensitivity (hyperinsulinemic-euglycemic clamp) assessments, in additional to assessments of cardiovascular and endothelial function.
Participants with type 1 diabetes using multiple daily injections plus a continuous glucose monitor will not be randomized to receive medication treatment but will undergo RPF (Aminohippurate Sodium Injections 20%), GFR (Iohexol Inj 300 MG/ML), and insulin sensitivity (hyperinsulinemic-euglycemic clamp) assessments, in additional to assessments of cardiovascular and endothelial function.