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NCT Number: NCT02731664

GLP-1 Inhibits Prandial Antro-duodeno-jejunal Motility in Humans

The inhibitory effect of low dose GLP-1 is investigated on prandial motility of the stomach, duodenum and jejunum in vivo in humans. Supplementary in vitro studies on the mechanism of action of the GLP-1 inhibition of motility as carried out on muscle strips from the upper gastrointestinal tract in man.

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Key information

Conditions

Functional Gastrointestinal Disorders Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Uppsala University

Uppsala, Uppsala County, 75185, Sweden

About this study

Twelve healthy volunteers will undergo antroduodenojejunal manometry. Baseline recording with infusion of saline for 1 hour is compared with infusion of GLP-1 0.7 and 1.2 pmol per kg minute for another 1 hour. Plasma GLP-1 and GLP-2 is measured by RIA. Responses to GLP-1 will be measured after food intake as prandial response to GLP-1. The outcome will be evaluated as change in motility index from baseline to meal-stimulated conditions and during influence of GLP-1. Further in vitro studies of gastrointestinal muscle strips, precontracted with bethanechol or electric field stimulation, are planned to investigate the response to GLP-1 or GLP-1 analogue ROSE-010. GLP-1 and GLP-2 receptor immunoreactivity is localized by immunohistochemistry. Receptor mediated mechanisms are studied with GLP-1 receptor blocker exendin(9-39)amide, nitro-monomethyl arginine to block nitric oxide synthase and tetrodotoxin to block sodium channels and nerve conduction.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteers over 18 years of age.

Exclusion criteria

  • Any medical condition.
  • Any drug treatment.

Treatment and study plan

GLP-1

Biological

Intravenous infusion of GLP-1

Other names: Glucagon-like peptide-1

Intravenous saline

Biological

Control

Primary outcomes

  1. Motility index (measure of contraction amplitude x duration; area for mmHg x sec)

    Time frame: 60 minutes

    Inhibition of prandially increased motility index (motor activity in the antrum and upper small intestine).

Secondary outcomes

  1. Smooth muscle relaxation induced by GLP-1

    Time frame: 6 hours

    Separate experiments in vitro: GLP-1-induced inhibition of bethanechol-stimulated smooth muscle strips to characterize GLP-1's pharmacological action.

  2. Presence of GLP-1 and GLP-2 receptors in gastric and small bowel tissue

    Time frame: 1 day

    Separate experiments in vitro: Antibody staining of gastric and small bowel tissue for receptors of GLP-1 and GLP-2

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Karolinska Institutet

Registry information

Official study title

GLP-1 Inhibits Prandial Antro-duodeno-jejunal Motility in Humans: Native GLP-1 Compared With Analogue ROSE-010 in Vitro

Acronym: GLPMOT

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Apr 7, 2016
Registry last updated
Aug 9, 2018

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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