Effects of Metformin and Automated Insulin Delivery on Youth with Type 1 Diabetes
MANATEE-T1D: Metformin ANd AutomaTEd Insulin Delivery System Effects on Renal Vascular Resistance, Insulin Sensitivity, and Cardiometabolic Function in Youth With Type 1 Diabetes
This study is testing if adding metformin and an automated insulin delivery system can help young people with type 1 diabetes improve their kidney and heart health.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 12 Years to 25 Years |
| Sex | All |
| Sponsor | Seattle Children's Hospital Academic / other |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Trial ID | NCT05065372 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of metformin and an automated insulin delivery system on renal vascular resistance, insulin sensitivity, and cardiometabolic function in youth aged 12-25 with type 1 diabetes. The study aims to understand how these interventions can improve kidney and cardiovascular outcomes, given the complexities of type 1 diabetes that extend beyond insulin deficiency. Participants will be monitored for changes in their health metrics while receiving either metformin or a placebo alongside their usual insulin regimen.
Who should consider this trial
Good fit: Ideal candidates are youth aged 12-25 with type 1 diabetes who have been using an automated insulin delivery system or multiple daily insulin injections for over six months.
Not a fit: Patients with significant kidney dysfunction or those on other anti-diabetic medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of kidney and cardiovascular health in young individuals with type 1 diabetes.
How similar studies have performed: Other studies have shown promising results with metformin in improving insulin sensitivity in type 1 diabetes, but the specific combination of interventions in this trial is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * T1D and using an automated insulin delivery system or multiple daily insulin injections/manual insulin pump plus continuous glucose monitor for \> 6 months * Age 12-25 years * Use of an automated insulin delivery system or multiple daily insulin injections plus a continuous glucose monitor or an insulin pump in manual mode plus a continuous glucose monitor for \> 6 months * Hemoglobin A1c \< 11% * No recent episodes of diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome (HHS) (within 30 days) * Pubertal (Tanner stage ≥ 2) * Weight \> 54 kg and BMI \> 5th percentile for age and sex Exclusion Criteria: * Blood pressure \> 140/90 mm Hg * Hemoglobin \< 9 g/dL * 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
Where this trial is running
Aurora, Colorado and 1 other locations
- 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)
Study contacts
- Study coordinator: Kalie Tommerdahl, MD
- Email: ktomme@uw.edu
- Phone: (206) 616-9015
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.