The purpose of the study is to evaluate the effect of sitagliptin on overall blood glucose concentrations in Type I Diabetic subjects. The study also aims to evaluate post meal glucagon concentrations in Type I Diabetic subjects (a possible mechanism of reduced blood glucose concentrations) and indices of oxidation stress in the plasma of these subjects.
The hypothesis is that Sitagliptin will improve overall blood glucose, fasting blood glucose, and glycemic excursions in patients with Type I Diabetes. In addition, sitagliptin will likely suppress indices of oxidative stress in patients. The study will investigate proposed mechanisms of improved glucose concentrations, including enhanced effect of endogenous GLP-1 and suppression of glucagon.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
sitagliptin 100mg by mouth once a day for 12 weeks
Take one by mouth daily for 12 weeks
115 Flint Road
Williamsville, New York, United States
change from baseline in mean glucose concentrations
The primary endpoint of the study is to detect the change from baseline in mean glucose concentrations as measured by both HbA1c, and mean glucose over the three days of continuous glucose monitoring.
Time frame: baseline and 3 months
Glycemic changes
Glycemic changes including standard deviations of the glycemic levels, fructosamine, and the duration of time spent in hyperglycemia and hypoglycemia.
Time frame: baseline and 3 months
Post meal hyperglycemia
Post meal hyperglycemia will be measured as area under the curve (AUC).
Time frame: baseline and 3 months
Changes in post prandial glucose, glucagon, insulin, c-peptide, DPP-IV, GIP and, GLP-1 concentrations following meal challenge.
Time frame: baseline and 3 months
Changes in NF kappa B in the fasting state.
Time frame: baseline and 3 months
Change in NFkappaB following meal challenge.
Time frame: baseline and 3 Months
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