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Completed

NCT Number: NCT00980083

GLP-1 - Regulatory Mechanism of Postprandial Glycemia

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.

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Key information

Conditions

Healthy Subjects Gastric Emptying

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Internal Medicine II, University of Munich

Munich, 81377, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saline

Drug

exendin(9-39)amide

Drug

Primary outcomes

  1. postprandial blood glucose levels

    Time frame: -50 min until 210 min after meal intake

Secondary outcomes

  1. gastric emptying rate

    Time frame: 0-210min

  2. plasma levels of glucagon, insulin

    Time frame: -50min until 210 min

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2007
First posted
Sep 18, 2009
Registry last updated
Sep 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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