Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00501657
Status:
COMPLETED
Last Update Posted:
2015-10-29
First Post:
2007-07-13
Brief Title:
Effects of Sitagliptin on Gastric Emptying in Healthy Subjects
Sponsor:
Royal Adelaide Hospital
Organization:
Royal Adelaide Hospital
Study Overview
Official Title:
Effects of Sitagliptin on Gastric Emptying in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None