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MANATEE-T1D: Metformin for Type 1 Diabetes in Youth

This study is looking at how Metformin (a drug that helps your body use insulin better) affects young people with Type 1 Diabetes. Researchers want to see if Metformin can improve how your kidneys' blood vessels work (renal vascular resistance) and how well your body responds to insulin (insulin sensitivity). They will also look at overall heart health. You might be eligible if you are 12-25 years old, have Type 1 Diabetes, and have been using an automated insulin delivery system or multiple daily insulin injections with a continuous glucose monitor for over six months. The study will measure kidney function (renal vascular resistance and glomerular filtration rate) after 4 months to see if Metformin is helpful. The current status of this study is unclear, and it plans to enroll 60 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 60 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at 4 months, suggesting follow-up for at least that duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05065372

MANATEE-T1D: Metformin ANd AutomaTEd Insulin Delivery System Effects on Renal Vascular Resistance, Insulin Sensitivity, and Cardiometabolic Function in Youth With Type 1 Diabetes

Recruiting
PHASE1Ages 12–25InterventionalTreatment
Kalie Tommerdahl
~60 participants
Updated 2025-06-13 on ClinicalTrials.gov
What's tested:Metformin Hcl 1000Mg TabAminohippurate Sodium 20 % InjectionIohexol 300 Mg/mL Injectable SolutionPlacebo

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Renal vascular resistance
Measured over 4 months
+1 more outcome measured

Conditions

Type 1 Diabetes
Diabetic Kidney Disease
Cardiovascular Diseases
Endothelial Dysfunction
Insulin Sensitivity

Explore related trials

Type 1 Diabetes Mellitus

Where it's being run

2 sites across 2 states
Colorado1
Washington1

Who to contact

Kalie Tommerdahl, MD
[email protected]
(206) 616-9015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Renal vascular resistance4 months

    Renal plasma flow will be measured by para-aminohippurate clearance and used to calculate renal vascular resistance

  • Glomerular filtration rate4 months

    Measured by iohexol clearance