GIP and GLP-1 on Gastric Emptying, Appetite and Insulin-glucose

Phase 1

Completed

• Conditions: Physiology; Gastroenterology; Endocrinology
• Interventions: Other: Glucose-insulinotropic peptide, Glucagon-like peptide-1

• Registration Number: NCT01079624
• Lead Sponsor: Uppsala University

Brief Summary

Academic phase 1 study which investigates the effects of the two incretin hormones glucose-insulinotropic peptide (GIP) and glucagon-like peptide-1 (GLP-1) on gastric emptying, appetite, insulin release and glucose disposal in the body. The hypothesis is that incretin hormones not only stimulate insulin release but also inhibits gastric emptying. This effect can be utilized for further drug development.

Detailed Description

Effects of GIP and GLP-1 on gastric emptying, appetite control and insulin release in relation to glucose levels in the bloodstream. Infusions of GIP and GLP-1 are given under simultaneous gastric emptying study and appetite questionnaires and blood sampling for analysis of insulin, glucose, and other gut hormones such as glucagon, ghrelin, and PYY, as well as those administered, GIP and GLP-1.

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2008-01
• Status Verified: 2009-07
• Study Completion: 2009-11
• Study First Submitted: 2010-03-02
• Study First Submitted QC: 2010-03-02
• Last Update Submitted: 2010-03-02
• Study First Posted: 2010-03-03
• Last Update Posted: 2010-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Men and women
• 18-50 years old;
• otherwise healthy and HIV and HCB, HCV negative

Exclusion Criteria

• Age >50,
• all types of diseases and drug users.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GIP two doses and GLP-1 one dose	Glucose-insulinotropic peptide, Glucagon-like peptide-1	Intervention with infusion of GIP or GLP-1 intravenously
Saline infusion	Glucose-insulinotropic peptide, Glucagon-like peptide-1	Control

Primary Outcome Measures

Name	Time	Method
Gastric emptying rate	2005-2006

Secondary Outcome Measures

Name	Time	Method
Plasma glucose, insulin release, appetite	2005-2006

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden