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GLP-1 Inhibits Prandial Antro-duodeno-jejunal Motility in Humans (GLPMOT)

U

Uppsala University

Status and phase

Completed
Phase 1

Conditions

Functional Gastrointestinal Disorders

Treatments

Biological: Intravenous saline
Biological: GLP-1

Study type

Interventional

Funder types

Other

Identifiers

NCT02731664
PRANDMOTGLP

Details and patient eligibility

About

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.

Full description

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.

Enrollment

12 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy volunteers over 18 years of age.

Exclusion criteria

  • Any medical condition.
  • Any drug treatment.

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

12 participants in 2 patient groups, including a placebo group

GLP-1
Experimental group
Description:
Intravenous infusion of GLP-1 at 0.7 and 1.2 mol/kg per minute
Treatment:
Biological: GLP-1
Control
Placebo Comparator group
Description:
Intravenous saline
Treatment:
Biological: Intravenous saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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