IMPROVING METABOLIC ASSESSMENTS IN TYPE 1 DIABETES MELLITUS CLINICAL TRIALS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The overall goal of this study is to select the metabolic test that would be best to use for intervention studies in subjects with T1D. The optimal conditions for the conduct of the test need to be determined. Important considerations for these choices include knowing the variability of the test and how sensitive the test is to detect changes in cell function. Equally important is selecting the test that is practical to conduct in the context of a large clinical trial. The choice of what measure of ?-cell function should be used as a primary outcome in clinical trials of type 1 diabetes depends upon balancing the need for scientific validity with the practical realities of performing the tests in a clinical trial setting. While fasting C-peptide alone is easy to do and may correlate well with stimulated C-peptide results, it may be insufficient to detect subtle effects of therapy. Post-clinical diagnosis, most studies involve a stimulated C-peptide response to non-glucose secretagogues. Europeans have most often used IV glucagon stimulated testing. This has the advantage of being a short test (6 minutes), but the disadvantage of causing transient nausea. Others have used C-peptide responses to a liquid mixed meal (Sustacal/Boost). Though this does not induce nausea, it does require more time. The study is a multi-center, two-arm, randomized clinical trial. Comparisons will be made between the two groups, with the primary objective of assessing the difference in reliability of the mixed meal tolerance test (MMTT) versus the IV glucagon infusion test.