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NCT01808690 · ClinicalTrials.gov registry record · Phase 3
EMERALD: Effects of Metformin on Cardiovascular Function in Adolescents With Type 1 Diabetes
A Phase 3 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 3
- Development phase
- 52
- Enrollment target
NCT01808690 is a Phase 3 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 52 participants.
The verdict
NCT01808690, a Phase 3 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 52 participants
- Enrollment target
Study Summary
Diabetes is increasingly common among youth, forecasting early complications. Type 1 (T1D) cause early heart disease, shortening lifespan despite modern improvements in control of blood sugars and other risk factors for heart disease. Poor insulin action, otherwise known as insulin resistance (IR), is the main factor causing heart disease in type 2 diabetes (T2D), but the cause of increased heart disease in T1D is unclear. IR may contribute to heart disease in T1D as in T2D, as the investigators and others have found the presence of IR in T1D. Much less is known about IR in T1D, but a better understanding of its role in T1D is critical to understanding causes of heart disease in T1D. The investigators long-term goal is to understand the early causes of heart disease in diabetes so that we can prevent it. The investigators unique initial findings suggest that even reasonably well-controlled, normal weight, T1D youth are IR. The IR appears directly related to the heart, blood vessel, and exercise defects, but in a pattern that appears very different from T2D. The goals of this study are to determine the unique heart, blood vessel and insulin sensitivity abnormalities in T1D youth, and determine whether metformin improves these abnormalities. A clear understanding of these factors will help determine the causes, and what treatments could help each abnormality. Hypothesis 1: Metformin will improve insulin function and mitochondrial function in T1D. Hypothesis 2: Metformin will improve vascular and cardiac function in T1D. All measures will be performed twice, before and after a 3-month randomized, placebo-controlled design where subjects are randomized to either metformin or placebo. The independent impact of insulin action as well as glucose levels, BMI, T1D duration, and gender on baseline outcomes and the impact of changes in insulin action, glucose levels and BMI on response to metformin will also be examined to help customize future strategies to prevent heart d
Interventions
- DRUG Placebo
- DRUG Metformin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2013-03 |
| Est. Completion | 2016-12-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01808690
The ClinicalTrials.gov registry entry for NCT01808690 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01808690 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01808690 about?
NCT01808690 is a clinical study titled "EMERALD: Effects of Metformin on Cardiovascular Function in Adolescents With Type 1 Diabetes". Diabetes is increasingly common among youth, forecasting early complications. Type 1 (T1D) cause early heart disease, shortening lifespan despite modern improvements in control of blood sugars and other risk factors for heart disease. Poor insulin action, otherwise known as insulin resistance (IR), ...
What is the current status of trial NCT01808690?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 52 participants. The study started on 2013-03. Estimated completion is 2016-12-02.
What interventions are being tested in trial NCT01808690?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG).
Who is sponsoring clinical trial NCT01808690?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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