Condition: Type 1 Diabetes · Diabetic Kidney Disease · Cardiovascular Diseases · Sponsor: Kalie Tommerdahl
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 sys…
This description comes directly from the study's public registry record.
Kalie Tommerdahl, MD · (206) 616-9015 · ktomme@uw.edu
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| Children's Hospital Colorado/University of Colorado Anschutz Medical Campus | Aurora, Colorado, United States | Active Not Recruiting |
| Seattle Children's Hospital | Seattle, Washington, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05065372