GLP-1 - Regulatory Mechanism of Postprandial Glycemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Healthy Subjects, Gastric Emptying

Intervention / Treatment
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* Drug: Saline
* Drug: Exendin(9-39)amide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Saline<br> <br> |
| Active Comparator: Exendin(9-39)<br> | Drug: Exendin(9-39)amide<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postprandial blood glucose levels |  | -50 min until 210 min after meal intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gastric emptying rate |  | 0-210min | 
| plasma levels of glucagon, insulin |  | -50min until 210 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GLP-1, exendin(9-39), gastric emptying, incretin, human