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Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Juvenile Diabetes Research Foundation National Center for Research Resources (NCRR) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00105352 |
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 evaluate comparability and reproducibility of measures of beta cell function in type 1 diabetes comparing the mixed meal tolerance tests (MMTT) and glucagon stimulation test (GST). These two tests will be compared to assess the relationship between the MMTT and IV (intravenous) Glucagon stimulated C-peptide responses as measured by time to peak C-peptide and AUC (area under the curve) values.
Based on the understanding that type 1 diabetes results from an immune mediated loss of pancreatic beta cells, therapeutic trials and newer measures of beta cell function can be evaluated as endpoints for clinical trials. Direct assessment of residual beta cell function is an appropriate endpoint, as retention of beta cell function in patients with T1D is known to result in improved glycemic control and reduced hypoglycemia, retinopathy and nephropathy. Endogenous beta cell function or insulin secretion is best measured by determination of C-peptide (which is co-secreted with insulin in a 1:1 molar ratio). Intervention studies over the past few decades have usually used measurement of C-peptide. However, the relationship between these or other measures of beta cell function has not been well studied. The relative advantages of one measure over another in terms of variability, sensitivity and burden to the subject is unknown. In addition, the optimal conditions for the conduct of the test need to be determined.
An important goal is to develop an international consensus about the conduct of metabolic tests in the context of large, multicenter trials involving type 1 diabetes (T1D) by balancing the scientific data with the burden on the subject.
Condition | Intervention |
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Diabetes Mellitus, Type 1 |
Procedure: Mixed Meal Tolerance Test Procedure: Glucagon Stimulation Test |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Improving Metabolic Assessments in Type 1 Diabetes Mellitus Clinical Trials |
Estimated Enrollment: | 120 |
Study Start Date: | November 2004 |
Study Completion Date: | November 2005 |
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 randomly start with either MMTT or GST.
Specific Aims
TEST INFORMATION:
BOOST is a liquid meal (like a milkshake) containing a standard amount of fat, protein, and carbohydrate. BOOST raises blood sugar and causes the pancreas to produce insulin. After drinking BOOST, about one-half teaspoon of blood will be drawn through an IV line in the arm after 15, 30, 60, 90, and 120 minutes. (Using an IV line avoids multiple needle sticks). The test takes about 2 hours.
Glucagon is a hormone that circulates in the blood and stimulates insulin secretion. Glucagon will be injected into the bloodstream through an IV line, and about one-half teaspoon of blood will be drawn five times during ten minutes. The test takes about 30 minutes.
OTHER TEST INFORMATION:
Ages Eligible for Study: | 8 Years to 35 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Exclusion Criteria:
United States, California | |
Children's Hospital Los Angeles | |
Los Angeles, California, United States, 90027 | |
Stanford University Medical Center | |
Stanford, California, United States, 94305-5208 | |
University of California San Francisco | |
San Francisco, California, United States, 94143-0434 | |
United States, Colorado | |
Barbara Davis Center for Childhood Diabetes, University of Colorado | |
Denver, Colorado, United States, 80262 | |
United States, Florida | |
University of Florida | |
Gainesville,, Florida, United States, 32610 | |
University of Miami School of Medicine | |
Miami, Florida, United States, 33101 | |
United States, Indiana | |
Riley Hospital for Children, Indiana University | |
Indianapolis, Indiana, United States, 46202 | |
United States, Massachusetts | |
Joslin Diabetes Center/ Children's Hospital Boston | |
Boston, Massachusetts, United States, 02215 | |
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 58944 | |
United States, New York | |
Naomi Berrie Diabetes Center, Columbia University | |
New York, New York, United States, 10032 | |
United States, Pennsylvania | |
Children's Hospital of Pittsburgh of UPMC | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Texas | |
University of Texas Medical Center at Dallas | |
Dallas, Texas, United States, 75390-8858 | |
United States, Washington | |
Benaroya Research Institute | |
Seattle, Washington, United States, 358285 | |
Australia, Victoria | |
Walter and Eliza Hall Institute of Medical Research | |
Parkville, Victoria, Australia, 3050 | |
Canada, Ontario | |
University of Toronto | |
Toronto, Ontario, Canada, M5G-1X8 | |
Finland | |
University of Turku | |
Turku, Finland, FIN-20520 | |
Italy | |
Vita-Salute San Raffaele University | |
Milan, Italy, +39-02-2643 2818 | |
United Kingdom | |
University of Bristol | |
Bristol, United Kingdom, BS10 5NB UK |
Study Chair: | Jay S Skyler, M.D. | University of Miami |
Study ID Numbers: | MMTTGST |
Study First Received: | March 11, 2005 |
Last Updated: | November 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00105352 |
Health Authority: | United States: Federal Government |
Type 1 Diabetes Study Group TrialNet type 1 diabetes juvenile onset diabetes |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Glucagon Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Immune System Diseases |