Effects of Sitagliptin on Gastric Emptying in Healthy Subjects

Royal Adelaide Hospital

Status and phase

Completed

Phase 1

Conditions

Gastroparesis

Diabetes Mellitus

Treatments

Drug: Sitagliptin

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00501657

061025

Details and patient eligibility

About

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.

Full description

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.

Enrollment

15 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.