Status:
COMPLETED
EMERALD: Effects of Metformin on Cardiovascular Function in Adolescents With Type 1 Diabetes
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
American Diabetes Association
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
12-21 years
Phase:
PHASE3
Brief 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 oth...
Eligibility Criteria
Inclusion
- Adolescents 12-21 years of age with type 1 diabetes (defined as having positive antibodies as well as insulin requirement)
- Willing to consent for participation in study
- Body Mass Index (BMI) \>5% on growth charts
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2016
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01808690
Start Date
March 1 2013
End Date
December 2 2016
Last Update
September 30 2021
Active Locations (1)
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1
Children's Hospital Colorado and University of Colorado Denver Health Sciences Center
Aurora, Colorado, United States, 80045