This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.OBJECTIVE: Examine optimal insulin therapy with the new insulin formulations from Novo Nordisk to determine if it reverses glucotoxicity (or 'glucolipotoxicity').RESEARCH PLAN: Thirty (30) patients with uncontrolled T2DM will be studied. After the initial screening visit all subjects will be admitted to the General Clinical Research Center (GCRC) for 2 1/2 days. Each subject will be admitted on three occasions: 1) pre-treatment; 2) Step 1 (after detemir alone x 12 weeks); and 3) Step 2 (after detemir plus aspart x 12 weeks). Following this, insulin aspart will be added to the treatment in 20 of the 30 patients (randomly chosen by a computer generated process) while the other 10 will be continued on insulin detemir alone. The outpatient and inpatient evaluations proposed above will be repeated.METHODS: In brief, the study design includes a two-step approach after the run-in baseline evaluations: Step 1: a three-month intensive insulin detemir (Levemir) treatment aimed at the best glycemic control possible with this unique insulin formulation. This will be followed by repeat measurements identical to those obtained at baseline. Step 2: addition of pre-meal insulin aspart (Novolog) for three months to examine the additional benefit of normalizing postprandial glucose excursions. Subjects will receive liver and muscle MRS scans.
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