GLP-1 - Regulatory Mechanism of Postprandial Glycemia

This study has been completed.
Sponsor:
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00980083
First received: September 17, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • gastric emptying rate [ Time Frame: 0-210min ] [ Designated as safety issue: No ]
  • plasma levels of glucagon, insulin [ Time Frame: -50min until 210 min ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Munich
ClinicalTrials.gov Identifier: NCT00980083     History of Changes
Other Study ID Numbers: MSE
Study First Received: September 17, 2009
Last Updated: September 17, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on August 01, 2014