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NCT05065372 · ClinicalTrials.gov registry record · Phase 1
MANATEE-T1D: Metformin ANd AutomaTEd Insulin Delivery System Effects on Renal Vascular Resistance, Insulin Sensitivity, and Cardiometabolic Function in Youth With Type 1 Diabetes
A Phase 1 study of Cardiovascular Diseases and Type 1 Diabetes, sponsored by Kalie Tommerdahl.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 2
- Study locations
NCT05065372: Recruiting Phase 1 study of Cardiovascular Diseases and Type 1 Diabetes, sponsored by Kalie Tommerdahl.
NCT05065372 is a Phase 1 study of Cardiovascular Diseases and Type 1 Diabetes that is actively recruiting participants, run by Kalie Tommerdahl. The registered enrollment target is 60 participants, below the 26,974-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05065372, a Phase 1 study of Cardiovascular Diseases and Type 1 Diabetes, is actively recruiting participants, sponsored by Kalie Tommerdahl.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
Renal plasma flow will be measured by para-aminohippurate clearance and used to calculate renal vascular resistance
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Metformin Hcl 1000Mg Tab
- DRUG Aminohippurate Sodium 20 % Injection
- DRUG Iohexol 300 Mg/mL Injectable Solution
Study Locations (2)
Colorado
- Children's Hospital Colorado/University of Colorado Anschutz Medical Campus - Aurora
Washington
- Seattle Children's Hospital - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-07-01 |
| Est. Completion | 2027-07-31 |
| Phase | Phase 1 |
What NCT05065372 shows while recruiting
NCT05065372 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 26,974-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (100% lower).
The record links to 5 conditions, with Cardiovascular Diseases appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT05065372 reports a single indexed study location in Colorado, Washington.
Frequently Asked Questions
What is clinical trial NCT05065372 about?
NCT05065372 is a clinical study titled "MANATEE-T1D: Metformin ANd AutomaTEd Insulin Delivery System Effects on Renal Vascular Resistance, Insulin Sensitivity, and Cardiometabolic Function in Youth With Type 1 Diabetes". 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 extend...
What is the current status of trial NCT05065372?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2022-07-01. Estimated completion is 2027-07-31.
What conditions does trial NCT05065372 study?
This clinical trial studies the following conditions: Cardiovascular Diseases, Type 1 Diabetes, Endothelial Dysfunction, Insulin Sensitivity, Diabetic Kidney Disease.
What interventions are being tested in trial NCT05065372?
The interventions under investigation include: Placebo (DRUG), Metformin Hcl 1000Mg Tab (DRUG), Aminohippurate Sodium 20 % Injection (DRUG), Iohexol 300 Mg/mL Injectable Solution (DRUG).
Who is sponsoring clinical trial NCT05065372?
This trial is sponsored by Kalie Tommerdahl, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05065372 being conducted?
This trial has 2 study locations across Colorado, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05065372's enrollment target sits among peer trials
60 222nd of 300 higher than 69 of 300 other Cardiovascular Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiovascular Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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