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EMERALD: Effects of Metformin on Cardiovascular Function in Adolescents With Type 1 Diabetes (EMERALD)
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Purpose
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 disease in T1D. This study will advance the field by providing new information about the role of poor insulin action in the heart disease of T1D, and whether improving insulin action in T1D is helpful. If a focus on directly improving insulin action in T1D youth is supported by our studies, the clinical approach to T1D management may significantly change.
| Condition | Intervention | Phase |
|---|---|---|
| Type 1 Diabetes | Drug: Metformin Drug: Placebo | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effects of Metformin on Cardiovascular Function in Adolescents With Type 1 Diabetes |
- Change in Insulin Function [ Time Frame: 3 months ]Hypothesis 1: Metformin will improve insulin function and mitochondrial function in Type 1 Diabetes. Insulin function will be measured using a euglycemic-hyperinsulinemic clamp procedure at both baseline and after 3 months of treatment.
- Change in Cardiovascular Function [ Time Frame: 3 months ]Hypothesis 2: Metformin will improve vascular and cardiac function in Type 1 Diabetes. Cardiac and vascular function will be measured using echocardiogram and vascular reactivity using inflatable cuffs.
| Enrollment: | 52 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | March 2018 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Metformin
Metformin will be given at a dose of 1000 mg twice a day orally for three months to assess changes in insulin resistance compared to placebo.
|
Drug: Metformin |
|
Placebo Comparator: Placebo
Placebo will be given at a dose of 1000 mg twice a day orally for three months to assess changes in insulin resistance compared to metformin.
|
Drug: Placebo |
Eligibility| Ages Eligible for Study: | 12 Years to 19 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adolescents 12-19 years of age with type 1 diabetes (defined as having positive antibodies as well as insulin requirement)
- Sedentary nature (<3 hours of physical activity/week)
- Willing to consent for participation in study
- Body Mass Index (BMI) >5% on growth charts
Exclusion Criteria:
- Current use of medications known to affect insulin sensitivity: oral glucocorticoids within 10 days, atypical antipsychotics, immunosuppressant agents, metformin or thiazolidinediones.
- Currently pregnant or breastfeeding women
- Use of a thiazolidinedione within 12 weeks
- Severe illness or Diabetic Ketoacidosis within 60 days
- Macroalbuminuria
- Hemoglobin A1c > 12%
- Weight > 136.4 kg or < 42 kg, BMI < 5%
- Creatinine > 1.2
- Hemoglobin < 9
- Major psychiatric or developmental disorder limiting informed consent
- Implanted metal devices
- Inability to tolerate ≥500mg twice a day of metformin
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01808690
| United States, Colorado | |
| Children's Hospital Colorado and University of Colorado Denver Health Sciences Center | |
| Aurora, Colorado, United States, 80045 | |
| Principal Investigator: | Kristen Nadeau, MD, MS | University of Colorado/Children's Hospital Colorado |
More Information
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT01808690 History of Changes |
| Other Study ID Numbers: |
12-1528 R56DK078645 ( U.S. NIH Grant/Contract ) |
| Study First Received: | March 6, 2013 |
| Last Updated: | December 19, 2016 |
Keywords provided by University of Colorado, Denver:
|
Adolescent Youth Diabetes |
Insulin Resistance Cardiovascular Metformin |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases |
Immune System Diseases Insulin Metformin Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 11, 2017