Actively Recruiting
MANATEE-T1D: Metformin ANd AutomaTEd Insulin Delivery System Effects on Renal Vascular Resistance, Insulin Sensitivity, and Cardiometabolic Function in Youth With Type 1 Diabetes
Led by Kalie Tommerdahl · Updated on 2025-06-13
60
Participants Needed
2
Research Sites
265 weeks
Total Duration
On this page
Sponsors
K
Kalie Tommerdahl
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Diabetic kidney disease and cardiovascular disease remain the leading causes of morbidity and mortality in people with type 1 diabetes and are exacerbated with longer duration of diabetes and time outside goal glycemic range. Yet, type 1 diabetes is a complex disease with pathophysiology that extends beyond beta-cell injury and insulin deficiency to include insulin resistance and renal vascular resistance, factors that accelerate cardiovascular disease risk. We have shown that metformin improved peripheral insulin sensitivity and vascular stiffness in youth with type 1 diabetes on multiple daily insulin injections or standard insulin pumps. However, metformin's effect on kidney and endothelial outcomes, and the effects of type 1 diabetes technologies, with or without metformin, on any cardiovascular or kidney outcome, remains unknown. Automated insulin delivery systems combine an insulin pump, continuous glucose monitor, and control algorithm to modulate background insulin delivery and decrease peripheral insulin exposure while improving time in target range and reducing hypoglycemia. We hypothesize that automated insulin delivery systems, particularly when combined with metformin, may modulate renal vascular resistance and insulin sensitivity, thereby impacting cardiometabolic function. MANATEE-T1D is a randomized, double-blind, placebo-controlled trial of 4 months of metformin 2,000 mg daily in 40 youth aged 12-25 years with type 1 diabetes on automated insulin delivery systems vs. 20 control youth with type 1 diabetes on multiple daily injections plus a continuous glucose monitor or an insulin pump in manual mode plus a continuous glucose monitor which will assess for changes in calculated renal vascular resistance and gold standard measures of whole-body and adipose insulin sensitivity, arterial stiffness, and endothelial function.
CONDITIONS
Official Title
MANATEE-T1D: Metformin ANd AutomaTEd Insulin Delivery System Effects on Renal Vascular Resistance, Insulin Sensitivity, and Cardiometabolic Function in Youth With Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with type 1 diabetes and using an automated insulin delivery system or multiple daily insulin injections/manual insulin pump plus a continuous glucose monitor for more than 6 months
- Age between 12 and 25 years
- Hemoglobin A1c less than 11%
- No diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome episodes within the past 30 days
- Pubertal with Tanner stage 2 or higher
- Weight over 54 kilograms and body mass index above the 5th percentile for age and sex
You will not qualify if you...
- Blood pressure above 140/90 mm Hg
- Hemoglobin level below 9 g/dL
- Estimated glomerular filtration rate below 60 mL/min/1.73 m2 or serum creatinine above 1.2 mg/dL, history of urinary albumin to creatinine ratio 300 mg/g or higher, or history of acute kidney injury
- Use of anti-diabetic agents other than insulin, ACE inhibitors, ARBs, diuretics, daily NSAIDs or aspirin, sulfonamides, procaine, thiazosulfone, or probenecid
- Allergy to seafood or iodine
- Pregnancy or breastfeeding for females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Children's Hospital Colorado/University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Active, Not Recruiting
2
Seattle Children's Hospital
Seattle, Washington, United States, 98102
Actively Recruiting
Research Team
K
Kalie Tommerdahl, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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