Status:
COMPLETED
Improving Metabolic Assessments in Type 1 Diabetes Mellitus Clinical Trials
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
8-35 years
Phase:
NA
Brief Summary
OBJECTIVE: This study is being conducted by the Type 1 Diabetes TrialNet Study Group, funded by the National Institutes of Health, in collaboration with the European C-Peptide Group. The goal is to e...
Detailed Description
Overview: The study is a multi-center, two-arm, randomized clinical trial. Each participant will undergo four tests within a limited period according to the test sequence assignment. The tests will r...
Eligibility Criteria
Inclusion
- Informed consent obtained from participants (over 12 years of age) and parents (for participants below 18 years of age). Assent is obtained from younger children.
- Age 8 - 35 years at the time of inclusion
- Body weight \> 30 kg
- Type 1 diabetes defined by: ADA (American Diabetes Association) criteria or judgment of physician
- Duration of diabetes: 1 month to 3\* years (\*The TrialNet Coordinating Center will monitor fasting C-peptide levels as they are reported to ensure that a wide range of values is included. This review may result in widening the duration of diabetes window to allow for subjects with low C-peptide).
- Must maintain good glycemic control
- Be willing to travel to a TrialNet Clinical Center for a minimum of four separate visits that are spaced 3-10 days apart, and be willing to complete the study within a six week period.
- Exclusion Criteria:
- Actual treatment with drugs influencing beta cell function (e.g. oral hypoglycaemic agents, beta-2-receptor agonists)
- Actual treatment with drugs influencing insulin sensitivity (e.g. steroids)
- Significant concomitant disease likely to interfere with glucose metabolism (e.g. febrile illness within the prior 3 days)
- Expected poor compliance
- If a female of child-bearing age, currently pregnant or not using a form of birth control
- Any other condition that by the judgement of the investigator may be potentially harmful to the patients
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00105352
Start Date
November 1 2004
End Date
November 1 2005
Last Update
June 2 2016
Active Locations (18)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
2
University of California San Francisco
San Francisco, California, United States, 94143-0434
3
Stanford University Medical Center
Stanford, California, United States, 94305-5208
4
Barbara Davis Center for Childhood Diabetes, University of Colorado
Denver, Colorado, United States, 80262