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

This study has been completed.
Sponsor:
Collaborators:
Karolinska Institutet
University of Copenhagen
Information provided by:
Uppsala University
ClinicalTrials.gov Identifier:
NCT01079624
First received: March 2, 2010
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Physiology
Gastroenterology
Endocrinology
 Other: Glucose-insulinotropic peptide, Glucagon-like peptide-1
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of GIP and GLP-1 on Gastric Emptying, Appetite and Insulin-glucose Homeostasis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Gastric emptying rate [ Time Frame: 2005-2006 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma glucose, insulin release, appetite [ Time Frame: 2005-2006 ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: August 2006
Study Completion Date: November 2009
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GIP two doses and GLP-1 one dose
Intervention with infusion of GIP or GLP-1 intravenously
 Other: Glucose-insulinotropic peptide, Glucagon-like peptide-1
GIP 2 and 5 pmol/kg min GLP-1 0.7 pmol/kg min
Other Names:
  • GIP
  • GLP-1
  • Saline
Placebo Comparator: Saline infusion
Control
 Other: Glucose-insulinotropic peptide, Glucagon-like peptide-1
GIP 2 and 5 pmol/kg min GLP-1 0.7 pmol/kg min
Other Names:
  • GIP
  • GLP-1
  • Saline

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01079624

Locations
Sweden
Karolinska University Hospital
Stockholm, Sweden, 17176
Sponsors and Collaborators
Uppsala University
Karolinska Institutet
University of Copenhagen
Investigators
Principal Investigator: Per M Hellstrom, MD, PhD Karolinska Institutet, Uppsala University
  More Information

No publications provided

Responsible Party: Professor Per Hellström, Uppsala University
ClinicalTrials.gov Identifier: NCT01079624     History of Changes
Other Study ID Numbers: GIP/GLP-gastric empt-APP-hor, K2010-55X -07916-24-3
Study First Received: March 2, 2010
Last Updated: March 2, 2010
Health Authority: Sweden: Institutional Review Board

Keywords provided by Uppsala University:
Incretin hormones
Glucose-insulinotropic peptide
Glucagon-like peptide-1
Gastric emptying
 Appetite
Glucose disposal
Gut hormones

Additional relevant MeSH terms:
Gastric Inhibitory Polypeptide
Glucagon-Like Peptide 1
Glucagon
Incretins
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013