GLP-1 - Regulatory Mechanism of Postprandial Glycemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2007-12-31

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.

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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.

Conditions

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Healthy Subjects Gastric Emptying

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Exendin(9-39)

Group Type ACTIVE_COMPARATOR

Exendin(9-39)amide

Intervention Type DRUG

Interventions

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Saline

Intervention Type DRUG

Exendin(9-39)amide

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes