GLP-1 – Regulatory Mechanism of Postprandial Glycemia

Overview

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.

Full Title of Study: “Endogenous GLP-1 Regulates Postprandial Glycaemia in Human: Relative Contributions of Insulin, Glucagon, and Gastric Emptying”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 2005

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.

Interventions

  • Drug: Saline
  • Drug: Exendin(9-39)amide

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
  • Active Comparator: Exendin(9-39)

Clinical Trial Outcome Measures

Primary Measures

  • postprandial blood glucose levels
    • Time Frame: -50 min until 210 min after meal intake

Secondary Measures

  • gastric emptying rate
    • Time Frame: 0-210min
  • plasma levels of glucagon, insulin
    • Time Frame: -50min until 210 min

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ludwig-Maximilians – University of Munich
  • Provider of Information About this Clinical Study
    • University of Munich,
  • Overall Official(s)
    • Joerg Schirra, Prof, Principal Investigator, University of Munich, Department of Internal Medicine II, Munich, Germany

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