Effects of Sitagliptin on Gastric Emptying in Healthy Subjects
Summary
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.
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.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Conditions
Gastroparesis
Intervention
Sitagliptin
Location
Discipline of Medicine, Royal Adelaide Hospital
Adelaide
South Australia
Australia
5000
Status
Not yet recruiting
Source
Royal Adelaide Hospital
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00501657
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Gastroparesis
Chronic delayed gastric emptying. Gastroparesis may be caused by motor dysfunction or paralysis of STOMACH muscles or may be associated with other systemic diseases such as DIABETES MELLITUS.
Gastric Dilatation
Abnormal distention of the STOMACH due to accumulation of gastric contents that may reach 10 to 15 liters. Gastric dilatation may be the result of GASTRIC OUTLET OBSTRUCTION; ILEUS; GASTROPARESIS; or denervation.
Clinical Trials
The Gastroparesis Registry (GpR) is an observational study to clarify the epidemiology, natural history, clinical course, and other outcomes of gastroparesis.
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PubMed Articles
Bloating in Gastroparesis: Severity, Impact, and Associated Factors.
OBJECTIVES:Bloating is commonly reported in gastroparesis, but its prevalence, impact, and associated factors are uninvestigated. We aimed to quantify the prevalence of bloating in gastroparesis and r...
To assess potential interactions between sitagliptin and metformin, we sought to characterize the in vitro inhibitory potency of sitagliptin on the uptake of MPP(+) and metformin, representative subst...
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Sitagliptin or exenatide once weekly for type 2 diabetes: comparison of the clinical trials.
Introduction: There is a need for new and improved treatments for type 2 diabetes. Glucagon-like peptide 1 (GLP-1) is a gut hormone that stimulates insulin secretion and the levels of GLP-1 can be inc...
Pharmacokinetic and pharmacodynamic evaluation of sitagliptin plus metformin.
Importance of the field: Type 2 diabetes is an increasingly prevalent disease resulting from various complex combinations of defects in insulin secretion and insulin action. Adequate blood glucose con...
