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

Physiology Clinical Trial

— GIP-GLP-gas  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01079624
• Other study ID #: GIP/GLP-gastric empt-APP-hor
• Secondary ID: K2010-55X -07916
• Status: Completed
• Phase: Phase 1
• First received: March 2, 2010
• Last updated: March 2, 2010
• Start date: August 2006
• Est. completion date: November 2009

Study information

• Verified date: July 2009
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2009
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Endocrinology
• Gastroenterology
• Physiology

Intervention

Other:
• Glucose-insulinotropic peptide, Glucagon-like peptide-1
GIP 2 and 5 pmol/kg min GLP-1 0.7 pmol/kg min

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Uppsala University	Karolinska Institutet, University of Copenhagen

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric emptying rate		2005-2006	No
Secondary	Plasma glucose, insulin release, appetite		2005-2006	No