- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02731664
GLP-1 Inhibits Prandial Antro-duodeno-jejunal Motility in Humans (GLPMOT)
August 7, 2018 updated by: Per Hellström, Uppsala University
GLP-1 Inhibits Prandial Antro-duodeno-jejunal Motility in Humans: Native GLP-1 Compared With Analogue ROSE-010 in Vitro
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Uppsala County
-
Uppsala, Uppsala County, Sweden, 75185
- Uppsala University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy volunteers over 18 years of age.
Exclusion Criteria:
- Any medical condition.
- Any drug treatment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GLP-1
Intravenous infusion of GLP-1 at 0.7 and 1.2 mol/kg per minute
|
Intravenous infusion of GLP-1
Other Names:
|
Placebo Comparator: Control
Intravenous saline
|
Control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
60 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 hours
|
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
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Per M. Hellström, MD, PhD, Uppsala University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2012
Primary Completion (Actual)
August 1, 2017
Study Completion (Actual)
August 1, 2017
Study Registration Dates
First Submitted
March 6, 2016
First Submitted That Met QC Criteria
April 6, 2016
First Posted (Estimate)
April 7, 2016
Study Record Updates
Last Update Posted (Actual)
August 9, 2018
Last Update Submitted That Met QC Criteria
August 7, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRANDMOTGLP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
On request.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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