GLP-1 - Regulatory Mechanism of Postprandial Glycemia

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00980083
• Other study ID #: MSE
• Status: Completed
• Phase: Phase 1
• First received: September 17, 2009
• Last updated: September 17, 2009
• Start date: October 2004
• Est. completion date: December 2007

Study information

• Verified date: September 2009
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2007
• Est. primary completion date: July 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Gastric Emptying
• Healthy Subjects

Intervention

Drug:
• Saline

• Exendin(9-39)amide

Locations

Country	Name	City	State
Germany	Department of Internal Medicine II, University of Munich	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postprandial blood glucose levels		-50 min until 210 min after meal intake	No
Secondary	gastric emptying rate		0-210min	No
Secondary	plasma levels of glucagon, insulin		-50min until 210 min	No