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

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ClinicalTrials.gov Identifier: NCT02731664
Recruitment Status : Recruiting
First Posted : April 7, 2016
Last Update Posted : August 4, 2016
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Per Hellström, Uppsala University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Functional Gastrointestinal Disorders Biological: GLP-1 Biological: Intravenous saline Phase 1

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: GLP-1 Inhibits Prandial Antro-duodeno-jejunal Motility in Humans: Native GLP-1 Compared With Analogue ROSE-010 in Vitro
Study Start Date : September 2012
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Glucagon

Arm Intervention/treatment
Experimental: GLP-1
Intravenous infusion of GLP-1 at 0.7 and 1.2 mol/kg per minute
Biological: GLP-1
Intravenous infusion of GLP-1
Other Name: Glucagon-like peptide-1

Placebo Comparator: Control
Intravenous saline
Biological: Intravenous saline
Control




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers over 18 years of age.

Exclusion Criteria:

  • Any medical condition.
  • Any drug treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02731664


Contacts
Contact: Per M. Hellström, MD, PhD +46 18 611 4285 Per.Hellstrom@medsci.uu.se
Contact: Dominic-Luc Webb, PhD +46 18 471 4721 Dominic-luc.Webb@medsci.uu.se

Locations
Sweden
Uppsala University Recruiting
Uppsala, Uppsala county, Sweden, 75185
Contact: Per M Hellstrom, MD, Prof    +46 70 3727423    Per.Hellstrom@medsci.uu.se   
Contact: Dominic-Luc Webb, PhD    +46 18 4714721    Dominic-Luc.Webb@medsci.uu.se   
Principal Investigator: Per M Hellström, MD, Prof         
Sponsors and Collaborators
Uppsala University
Karolinska Institutet
Investigators
Principal Investigator: Per M. Hellström, MD, PhD Uppsala University

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Per Hellström, Professor, Uppsala University
ClinicalTrials.gov Identifier: NCT02731664     History of Changes
Other Study ID Numbers: PRANDMOTGLP
First Posted: April 7, 2016    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: On request.

Keywords provided by Per Hellström, Uppsala University:
Irritable bowel syndrome
Functional dyspepsia
Gastric emptying
Gastrointestinal peptide hormones

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases
Glucagon-Like Peptide 1
Glucagon
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Gastrointestinal Agents