Improving Metabolic Assessments in Type 1 Diabetes Mellitus Clinical Trials
Completed · Not applicable
Conditions studied: Diabetes Mellitus, Type 1
In brief
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.
Key facts
- Study ID
- NCT00105352
- Run by
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- People needed
- 120
- Starts
- 2004-11-01
- Expected to finish
- 2005-11-01
- Last updated by the study team
- 2016-06-02
Who can join
Age: 8 and older, up to 35. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Children's Hospital Los Angeles — Los Angeles, California, United States
- University of California San Francisco — San Francisco, California, United States
- Stanford University Medical Center — Stanford, California, United States
- Barbara Davis Center for Childhood Diabetes, University of Colorado — Denver, Colorado, United States
- University of Florida — Gainesville, Florida, United States
- University of Miami School of Medicine — Miami, Florida, United States
- Riley Hospital for Children, Indiana University — Indianapolis, Indiana, United States
- Joslin Diabetes Center/ Children's Hospital Boston — Boston, Massachusetts, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- Naomi Berrie Diabetes Center, Columbia University — New York, New York, United States
- Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
- University of Texas Medical Center at Dallas — Dallas, Texas, United States
- Benaroya Research Institute — Seattle, Washington, United States
- Walter and Eliza Hall Institute of Medical Research — Parkville, Victoria, Australia
- University of Toronto — Toronto, Ontario, Canada
- University of Turku — Turku, Finland
- Vita-Salute San Raffaele University — Milan, Italy
- University of Bristol — Bristol, United Kingdom
Full record on ClinicalTrials.gov
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