Back to resultsThe Effect of Oxytocin on Gastric Emptying
Primary Purpose
Dyspepsia, Lack of Satiety
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
oxytocin
Sponsored by
About this trial
This is an interventional treatment trial for Dyspepsia focused on measuring oxytocin, satiety, dyspepsia
Eligibility Criteria
Inclusion Criteria:
- Dyspepsia
Exclusion Criteria:
- Age > 65 years
- Cardiac disease
Sites / Locations
- Skåne University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
oxytocin, satiety
Arm Description
Oxytocin is given as infusion to examine if this decreases satiety compared to saline during a drinking test
Outcomes
Primary Outcome Measures
Satiety
The investigator want to examine whether oxytocin leads to lower satiety scores after intake of the same volume of nutrient
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01152047
Brief Title
The Effect of Oxytocin on Gastric Emptying
Official Title
The Effect of Oxytocin on Satiety in Patients With Dyspepsia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Skane University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia, Lack of Satiety
Keywords
oxytocin, satiety, dyspepsia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oxytocin, satiety
Arm Type
Experimental
Arm Description
Oxytocin is given as infusion to examine if this decreases satiety compared to saline during a drinking test
Intervention Type
Drug
Intervention Name(s)
oxytocin
Other Intervention Name(s)
syntocinon
Intervention Description
40mU/min as infusion of oxytocin
Primary Outcome Measure Information:
Title
Satiety
Description
The investigator want to examine whether oxytocin leads to lower satiety scores after intake of the same volume of nutrient
Time Frame
2 h
Other Pre-specified Outcome Measures:
Title
To see if oxytocin lowers satiety
Description
To perform a drinking satiety test twice. Once with oxytocin and once with saline. Then examine whether oxytocin decreases satiety compared to saline
Time Frame
2h
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Dyspepsia
Exclusion Criteria:
Age > 65 years
Cardiac disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bodil Ohlsson, professor
Organizational Affiliation
Divsion of Internal Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skåne University Hospital
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
The Effect of Oxytocin on Gastric Emptying
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