GLP-1 - Regulatory Mechanism of Postprandial Glycemia
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Subjects Gastric Emptying |
Drug: Saline Drug: Exendin(9-39)amide |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | Endogenous GLP-1 Regulates Postprandial Glycaemia in Human: Relative Contributions of Insulin, Glucagon, and Gastric Emptying |
- postprandial blood glucose levels [ Time Frame: -50 min until 210 min after meal intake ] [ Designated as safety issue: No ]
- gastric emptying rate [ Time Frame: 0-210min ] [ Designated as safety issue: No ]
- plasma levels of glucagon, insulin [ Time Frame: -50min until 210 min ] [ Designated as safety issue: No ]
| Enrollment: | 12 |
| Study Start Date: | October 2004 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo | Drug: Saline |
| Active Comparator: Exendin(9-39) | Drug: Exendin(9-39)amide |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Germany | |
| Department of Internal Medicine II, University of Munich | |
| Munich, Germany, 81377 | |
| Principal Investigator: | Joerg Schirra, Prof | University of Munich, Department of Internal Medicine II, Munich, Germany |
More Information
No publications provided
| Responsible Party: | University of Munich |
| ClinicalTrials.gov Identifier: | NCT00980083 History of Changes |
| Other Study ID Numbers: | MSE |
| Study First Received: | September 17, 2009 |
| Last Updated: | September 17, 2009 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Ludwig-Maximilians - University of Munich:
|
GLP-1 exendin(9-39) gastric emptying incretin human |
ClinicalTrials.gov processed this record on May 23, 2013