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GLP-1 - Regulatory Mechanism of Postprandial Glycemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00980083
First Posted: September 18, 2009
Last Update Posted: September 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ludwig-Maximilians - University of Munich
  Purpose
Synthetic GLP-1 lowers postprandial (pp) glycemia by stimulating insulin, inhibiting glucagon, and delaying gastric emptying. However, the effects of the endogenous peptide are largely unknown. Using the specific GLP-1 receptor antagonist exendin(9-39)amide (Ex(9-39)) the investigators recently showed that GLP-1 released during intestinal meal perfusion acts as an incretin hormone and as an enterogastrone. As the relative contributions of these effects to controll postprandial glycemia are unclear, the investigators used Ex(9-39) to investigate the mechanisms of action of GLP-1 after an oral meal in humans.

Condition Intervention Phase
Healthy Subjects Gastric Emptying Drug: Saline Drug: Exendin(9-39)amide Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Endogenous GLP-1 Regulates Postprandial Glycaemia in Human: Relative Contributions of Insulin, Glucagon, and Gastric Emptying

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • postprandial blood glucose levels [ Time Frame: -50 min until 210 min after meal intake ]

Secondary Outcome Measures:
  • gastric emptying rate [ Time Frame: 0-210min ]
  • plasma levels of glucagon, insulin [ Time Frame: -50min until 210 min ]

Enrollment: 12
Study Start Date: October 2004
Study Completion Date: December 2007
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Saline
Active Comparator: Exendin(9-39) Drug: Exendin(9-39)amide

Detailed Description:
Two experiments were performed in random order in 12 healthy subjects. After a 50-min basal period subjects ingested a 412 kcal mixed semisolid meal containing 30g oatmeal, labelled with 99mTc-Sn-colloid. Gastric emptying was measured by high-resolution scintigraphy until 210 min after meal ingestion. Saline (SAL) or Ex(9-39) at 900 pmol/kg/min was intravenously infused during the two experiments. In addition, in 6 of the 12 subjects gastric motility was measured by antroduodenal manometry and gastric barostat. AUC: pp incremental area under the curve. Lag period (LP): time to 10% emptying.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subject
  • >=18 years of age
  • No medication

Exclusion Criteria:

  • Acute disease
  • Metabolic disease
  • On medication
  • Pregnancy, breast feeding
  • Gastrointestinal surgery
  • Dyspeptische Symptome (Völlegefühl, Blähungen, abdominelle Schmerzereignisse, Übelkeit, Erbrechen, Sodbrennen)
  • Teilnahme an einer klinischen Studie in den vergangenen 6 Monaten
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00980083


Locations
Germany
Department of Internal Medicine II, University of Munich
Munich, Germany, 81377
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
Principal Investigator: Joerg Schirra, Prof University of Munich, Department of Internal Medicine II, Munich, Germany
  More Information

Responsible Party: University of Munich
ClinicalTrials.gov Identifier: NCT00980083     History of Changes
Other Study ID Numbers: MSE
First Submitted: September 17, 2009
First Posted: September 18, 2009
Last Update Posted: September 18, 2009
Last Verified: September 2009

Keywords provided by Ludwig-Maximilians - University of Munich:
GLP-1
exendin(9-39)
gastric emptying
incretin
human