- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01152047
The Effect of Oxytocin on Gastric Emptying
April 6, 2015 updated by: Bodil Ohlsson, Skane University Hospital
The Effect of Oxytocin on Satiety in Patients With Dyspepsia
The investigators have seen that oxytocin lowers satiety in healthy subjects.
Patients with dyspepsia suffers from decreased accommodation and increased satiety postprandially.
The investigators now want to examine whether oxytocin may diminish symptoms in these patients.
Study Overview
Detailed Description
Patients will come twice for a slow satiety drinking test.
Once they will get saline infusion and once oxytocin 40 mU/min.
At the same time they register satiety on a VAS scale.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
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
-
-
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Malmö, Sweden, 205 02
- Skåne University Hospital
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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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Dyspepsia
Exclusion Criteria:
- Age > 65 years
- Cardiac disease
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: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: oxytocin, satiety
Oxytocin is given as infusion to examine if this decreases satiety compared to saline during a drinking test
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40mU/min as infusion of oxytocin
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satiety
Time Frame: 2 h
|
The investigator want to examine whether oxytocin leads to lower satiety scores after intake of the same volume of nutrient
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2 h
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To see if oxytocin lowers satiety
Time Frame: 2h
|
To perform a drinking satiety test twice.
Once with oxytocin and once with saline.
Then examine whether oxytocin decreases satiety compared to saline
|
2h
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bodil Ohlsson, professor, Divsion of Internal Medicine
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
May 1, 2010
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
June 23, 2010
First Submitted That Met QC Criteria
June 28, 2010
First Posted (Estimate)
June 29, 2010
Study Record Updates
Last Update Posted (Estimate)
April 7, 2015
Last Update Submitted That Met QC Criteria
April 6, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009/502 (Other Identifier: Regional Ethical Review Board)
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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