Improving Metabolic Assessments in Type 1 Diabetes Mellitus Clinical Trials
1 other identifier
interventional
120
6 countries
18
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2004
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 11, 2005
CompletedFirst Posted
Study publicly available on registry
March 14, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedJune 2, 2016
June 1, 2016
March 11, 2005
June 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Stimulated C-peptide response derived from the 2-hour MMTT and the glucagon stimulation test (GST)
Time to peak C-peptide on MMTT, and the peak and AUC values from each test
Co-efficient of reproducibility of the MMTT, and the GST, provided from the duplicate tests within the same individuals
Interventions
Eligibility Criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)lead
- National Institute of Allergy and Infectious Diseases (NIAID)collaborator
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)collaborator
- Juvenile Diabetes Research Foundationcollaborator
- National Center for Research Resources (NCRR)collaborator
Study Sites (18)
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
University of California San Francisco
San Francisco, California, 94143-0434, United States
Stanford University Medical Center
Stanford, California, 94305-5208, United States
Barbara Davis Center for Childhood Diabetes, University of Colorado
Denver, Colorado, 80262, United States
University of Florida
Gainesville, Florida, 32610, United States
University of Miami School of Medicine
Miami, Florida, 33101, United States
Riley Hospital for Children, Indiana University
Indianapolis, Indiana, 46202, United States
Joslin Diabetes Center/ Children's Hospital Boston
Boston, Massachusetts, 02215, United States
University of Minnesota
Minneapolis, Minnesota, 58944, United States
Naomi Berrie Diabetes Center, Columbia University
New York, New York, 10032, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15213, United States
University of Texas Medical Center at Dallas
Dallas, Texas, 75390-8858, United States
Benaroya Research Institute
Seattle, Washington, 358285, United States
Walter and Eliza Hall Institute of Medical Research
Parkville, Victoria, 3050, Australia
University of Toronto
Toronto, Ontario, M5G-1X8, Canada
University of Turku
Turku, FIN-20520, Finland
Vita-Salute San Raffaele University
Milan, +39-02-2643 2818, Italy
University of Bristol
Bristol, BS10 5NB UK, United Kingdom
Related Publications (3)
Palmer JP, Fleming GA, Greenbaum CJ, Herold KC, Jansa LD, Kolb H, Lachin JM, Polonsky KS, Pozzilli P, Skyler JS, Steffes MW. C-peptide is the appropriate outcome measure for type 1 diabetes clinical trials to preserve beta-cell function: report of an ADA workshop, 21-22 October 2001. Diabetes. 2004 Jan;53(1):250-64. doi: 10.2337/diabetes.53.1.250.
PMID: 14693724BACKGROUNDGreenbaum CJ, Harrison LC; Immunology of Diabetes Society. Guidelines for intervention trials in subjects with newly diagnosed type 1 diabetes. Diabetes. 2003 May;52(5):1059-65. doi: 10.2337/diabetes.52.5.1059. No abstract available.
PMID: 12716733BACKGROUNDGreenbaum CJ, Mandrup-Poulsen T, McGee PF, Battelino T, Haastert B, Ludvigsson J, Pozzilli P, Lachin JM, Kolb H; Type 1 Diabetes Trial Net Research Group; European C-Peptide Trial Study Group. Mixed-meal tolerance test versus glucagon stimulation test for the assessment of beta-cell function in therapeutic trials in type 1 diabetes. Diabetes Care. 2008 Oct;31(10):1966-71. doi: 10.2337/dc07-2451. Epub 2008 Jul 15.
PMID: 18628574DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jay S Skyler, M.D.
University of Miami
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- NIH
Study Record Dates
First Submitted
March 11, 2005
First Posted
March 14, 2005
Study Start
November 1, 2004
Study Completion
November 1, 2005
Last Updated
June 2, 2016
Record last verified: 2016-06