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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin | Experimental | Sitagliptin 100 mg given 2 hours prior to the oral glucose tolerance test |
|
| Placebo | Placebo Comparator | Placebo given 2 hours prior to the oral glucose tolerance test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Glucose Tolerance Test | Procedure | Three hour glucose tolerance test |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve for insulin concentration | Area under the curve of insulin concentration measured from oral glucose tolerance test using trapezoidal rule | 6 weeks |
| Area under the curve for glucose concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Parameters of a mathematical model (insulin secretion and glucose sensitivity of the β-cell | We will apply mathematical modeling to the oral glucose tolerance test data it assess measures of insulin secretion and glucose sensitivity of the β-cell | 6 weeks |
Inclusion Criteria:
• Age: >18 years old
Exclusion Criteria:
• Pregnancy (reproductive age women will undergo pregnancy tests immediately before receiving the drug)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amber L Beitelshees | Contact | 14107060118 | abeitels@som.umaryland.edu | |
| Kamah Woelfel | Contact | KWoelfel@som.umaryland.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amber L Beitelshees, PharmD, MPH | University of Maryland, Baltimore | Principal Investigator |
| Simeon I Taylor, MD, PhD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Amish Research Clinic | Lancaster | Pennsylvania | 17602 | United States |
Given that the Amish are a unique founder population, they are more easily identified and at-risk for stigmatization. Therefore, we must consult with the community in order to address this plan to share individual level data.
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D005951 | Glucose Tolerance Test |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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Area under the curve for glucose concentration measured from the oral glucose tolerance test using the trapezoidal rule
| 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 | 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 | 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 | 6 weeks |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008919 | Investigative Techniques |