This is a research study to find out how different people respond to a medication called sitagliptin. Sitagliptin is an FDA approved medication that is used to treat diabetes. We are asking for healthy, non-diabetic volunteers to participate in this 7-week study. If you agree to participate, you will take part in 2 clinic visits that are 4-6 weeks apart. At the clinic visits you will have an oral glucose tolerance test (OGTT) and other blood tests to see how your body processes glucose (sugar). An OGTT is a test in which your drink glucose and then blood samples are taken afterward at specific time points to measure glucose and insulin in your blood. Each clinic visit will last about 5 hours.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
400
Three hour glucose tolerance test
University of Maryland Amish Research Clinic
Lancaster, Pennsylvania, United States
Sitagliptin-induced enhancement of early insulin secretion
This represents the incretinomimetic effect of sitagliptin, which contributes importantly to the mechanism whereby DPP4is decrease HbA1c in T2D patients. Because histograms for sitagliptin-induced increase in our index of early insulin secretion (T30:T60) demonstrated a skewed distribution, we will apply a logarithmic transformation of data which yields a normal distribution. Thus, the drug effect is defined as: log(T30:T60 ins)sita - log(T30:T60 ins)control.
Time frame: 6 weeks
Sitagliptin-induced change in glucose tolerance
Sitagliptin-induced change in glucose tolerance. This is a consequence of enhanced insulin secretion, which reflects most closely the desired effect of the drug to decrease plasma glucose and decrease HbA1c. Because histograms for sitagliptin-induced increase in our index of glucose tolerance (T30:T60) demonstrated a skewed distribution, we will apply a logarithmic transformation of data which yields a normal distribution. Thus, the drug effect is defined as: log(T30:T60 gluc)sita - log(T30:T60 gluc)control.
Time frame: 6 weeks
Area under the curve for insulin concentration
Area under the curve of insulin concentration measured from oral glucose tolerance test using trapezoidal rule
Time frame: 6 weeks
Area under the curve for glucose concentration
Area under the curve for glucose concentration measured from the oral glucose tolerance test using the trapezoidal rule
Time frame: 6 weeks
Area under the curve for intact GIP
Area under the curve for levels of intact GIP during the first hour of the OGTT as calculated by the trapezoidal rule
Time frame: 6 weeks
Area under the curve for intact GLP1
Area under the curve for levels of intact GLP1 during the first hour of the OGTT as calculated by the trapezoidal rule
Time frame: 6 weeks
Area under the curve for C-peptide levels
Area under the curve for C-peptide levels as a direct index of insulin secretion
Time frame: 6 weeks
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