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

March 2, 2010 updated by: Uppsala University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 17176
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Saline
  • GIP
  • GLP-1
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:
  • Saline
  • GIP
  • GLP-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gastric emptying rate
Time Frame: 2005-2006
2005-2006

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma glucose, insulin release, appetite
Time Frame: 2005-2006
2005-2006

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

Karolinska Institutet
University of Copenhagen

Investigators

  • Principal Investigator: Per M Hellstrom, MD, PhD, Karolinska Institutet, Uppsala University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (ACTUAL)

January 1, 2008

Study Completion (ACTUAL)

November 1, 2009

Study Registration Dates

First Submitted

March 2, 2010

First Submitted That Met QC Criteria

March 2, 2010

First Posted (ESTIMATE)

March 3, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 3, 2010

Last Update Submitted That Met QC Criteria

March 2, 2010

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIP/GLP-gastric empt-APP-hor
  • K2010-55X -07916-24-3 (OTHER_GRANT: Swedish Research Council)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Physiology

Clinical Trials on Glucose-insulinotropic peptide, Glucagon-like peptide-1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe