Effects of Sitagliptin on Gastric Emptying in Healthy Subjects

Study Overview
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Brief Summary
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The purpose of this study is to determine the effects of the drug, sitagliptin, on the rate at which the stomach empties, and the release of gut hormones and blood glucose concentrations, after a mashed potato meal in healthy subjects. Sitagliptin has been shown to reduce the blood glucose (sugar) response to a meal and this may potentially be due to slowing of stomach emptying. This is particularly relevant to people who have diabetes, in whom normalization of elevated blood glucose levels is important to maintain health.

Detailed Description
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The purpose of this study is to evaluate the effect of sitagliptin on gastric emptying, intragastric meal distribution, postprandial glycemia and insulinemia in healthy subjects. Glucagon-like peptide-1 (GLP-1) inhibits gastric emptying, thereby slowing the delivery of nutrients, and their absorption, across the small intestine. The rate of entry of carbohydrate into the small intestine is especially important in patients with diabetes mellitus. Sitagliptin is an orally administered inhibitor of dipeptidyl-peptidase-IV (DPP-IV), the enzyme responsible for the degradation of GLP-1. It is hypothesized that sitagliptin will increase the GLP-1 response to, and thereby slow gastric emptying and diminish the glycemic response to, a carbohydrate-containing meal. Fifteen healthy subjects (male and female) will be studied. Each subject will be studied on two occasions following treatment for 2 days with sitagliptin (100mg once daily) or matching placebo in a randomized, double blind, crossover design. Measurements of gastric emptying, intragastric meal distribution, blood glucose concentrations, gut hormones and appetite will be measured for 4 hours following ingestion of a mashed potato meal.

Official Title
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Effects of Sitagliptin on Gastric Emptying in Healthy Subjects

Conditions
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Gastroparesis, Diabetes Mellitus

Intervention / Treatment
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* Drug: Sitagliptin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female (females must be using an appropriate contraceptive method) 18 - 45 years Body mass index (BMI) 19 - 25 kg/m2. Exclusion criteria: Subjects with gastrointestinal disease, history of gastrointestinal surgery and/or significant gastrointestinal symptoms Subjects taking medication known to influence gastrointestinal function Alcohol intake > 20 g per day Smoking > 10 cigarettes per day Pregnant and/or lactating females Calculated creatinine clearance < 60 ml/min Exposure to ionising radiation for research purposes in the previous 12 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sitagliptin (100mg)<br>Active drug (sitagliptin) | Drug: Sitagliptin<br>* 100mg mane for 2 days<br>* Other names: Januvia;|
| Placebo Comparator: Placebo (sugar pill)<br>Inactive drug (placebo) | Drug: Placebo<br>* 100mg mane for 2 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying rate |  | 4 hours per study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intragastric distribution, gastrointestinal hormone release (GLP-1, GIP), glycemia, insulinemia, appetite |  | 4 hours per study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric emptying, glycemia, appetite, incretin hormones