NCT02731664

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2012

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 7, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

4.9 years

First QC Date

March 6, 2016

Last Update Submit

August 7, 2018

Conditions

Functional Gastrointestinal Disorders

Keywords

Irritable bowel syndromeFunctional dyspepsiaGastric emptyingGastrointestinal peptide hormones

Outcome Measures

Primary Outcomes (1)

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

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

    60 minutes

Secondary Outcomes (2)

  • Smooth muscle relaxation induced by GLP-1

    6 hours

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

    1 day

Study Arms (2)

GLP-1

EXPERIMENTAL

Intravenous infusion of GLP-1 at 0.7 and 1.2 mol/kg per minute

Biological: GLP-1

Control

PLACEBO COMPARATOR

Intravenous saline

Biological: Intravenous saline

Interventions

GLP-1BIOLOGICAL

Intravenous infusion of GLP-1

Also known as: Glucagon-like peptide-1
GLP-1
Intravenous salineBIOLOGICAL

Control

Control

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers over 18 years of age.

You may not qualify if:

  • Any medical condition.
  • Any drug treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University

Uppsala, Uppsala County, 75185, Sweden

Location

Related Publications (4)

  • Edholm T, Degerblad M, Gryback P, Hilsted L, Holst JJ, Jacobsson H, Efendic S, Schmidt PT, Hellstrom PM. Differential incretin effects of GIP and GLP-1 on gastric emptying, appetite, and insulin-glucose homeostasis. Neurogastroenterol Motil. 2010 Nov;22(11):1191-200, e315. doi: 10.1111/j.1365-2982.2010.01554.x.

    PMID: 20584260BACKGROUND

  • Hellstrom PM, Hein J, Bytzer P, Bjornsson E, Kristensen J, Schambye H. Clinical trial: the glucagon-like peptide-1 analogue ROSE-010 for management of acute pain in patients with irritable bowel syndrome: a randomized, placebo-controlled, double-blind study. Aliment Pharmacol Ther. 2009 Jan;29(2):198-206. doi: 10.1111/j.1365-2036.2008.03870.x. Epub 2008 Oct 10.

    PMID: 18945254BACKGROUND

  • Hellstrom PM, Naslund E, Edholm T, Schmidt PT, Kristensen J, Theodorsson E, Holst JJ, Efendic S. GLP-1 suppresses gastrointestinal motility and inhibits the migrating motor complex in healthy subjects and patients with irritable bowel syndrome. Neurogastroenterol Motil. 2008 Jun;20(6):649-59. doi: 10.1111/j.1365-2982.2007.01079.x. Epub 2008 Feb 19.

    PMID: 18298441RESULT

  • Halim MA, Degerblad M, Sundbom M, Karlbom U, Holst JJ, Webb DL, Hellstrom PM. Glucagon-Like Peptide-1 Inhibits Prandial Gastrointestinal Motility Through Myenteric Neuronal Mechanisms in Humans. J Clin Endocrinol Metab. 2018 Feb 1;103(2):575-585. doi: 10.1210/jc.2017-02006.

    PMID: 29177486DERIVED

MeSH Terms

Conditions

Gastrointestinal DiseasesIrritable Bowel Syndrome

Interventions

Glucagon-Like Peptide 1

Condition Hierarchy (Ancestors)

Digestive System DiseasesColonic Diseases, FunctionalColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Per M. Hellström, MD, PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 6, 2016

First Posted

April 7, 2016

Study Start

September 1, 2012

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

August 9, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will share

On request.

Locations

SE(1)