GLP-1 - Regulatory Mechanism of Postprandial Glycemia

Phase 1

Completed

• Conditions: Healthy Subjects; Gastric Emptying
• Interventions: Drug: Saline; Drug: Exendin(9-39)amide

• Registration Number: NCT00980083
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-10
• Primary Completion: 2005-07
• Study Completion: 2007-12
• Status Verified: 2009-09
• Study First Submitted: 2009-09-17
• Study First Submitted QC: 2009-09-17
• Last Update Submitted: 2009-09-17
• Study First Posted: 2009-09-18
• Last Update Posted: 2009-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Saline	-
Exendin(9-39)	Exendin(9-39)amide	-

Primary Outcome Measures

Name	Time	Method
postprandial blood glucose levels	-50 min until 210 min after meal intake

Secondary Outcome Measures

Name	Time	Method
gastric emptying rate	0-210min
plasma levels of glucagon, insulin	-50min until 210 min

Trial Locations

Locations (1)

Department of Internal Medicine II, University of Munich; 🇩🇪 Munich, Germany