The Effect of Oxytocin on Gastric Emptying

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Skane University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Skane University Hospital
ClinicalTrials.gov Identifier:
NCT01152047
First received: June 23, 2010
Last updated: June 28, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention
Dyspepsia
Satiety
Drug: oxytocin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: The Effect of Oxytocin on Satiety in Patients With Dyspepsia

Resource links provided by NLM:


Further study details as provided by Skane University Hospital:

Primary Outcome Measures:
  • Satiety [ Time Frame: 2 h ] [ Designated as safety issue: No ]
    The investigator want to examine whether oxytocin leads to lower satiety scores after intake of the same volume of nutrient

  • To see if oxytocin lowers satiety [ Time Frame: 2h ] [ Designated as safety issue: No ]
    To perform a drinking satiety test twice. Once with oxytocin and once with saline. Then examine whether oxytocin decreases satiety compared to saline


Estimated Enrollment: 30
Study Start Date: May 2010
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oxytocin, satiety
Oxytocin is given as infusion to examine if this decreases satiety compared to saline during a drinking test
Drug: oxytocin
40mU/min as infusion of oxytocin

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Dyspepsia

Exclusion Criteria:

  • Age > 65 years
  • Cardiac disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01152047

Locations
Sweden
Skåne University Hospital Recruiting
Malmö, Sweden, 205 02
Contact: bodil ohlsson, MD, PhD    +46+40332323    bodil.ohlsson@med.lu.se   
Principal Investigator: Bodil Ohlsson, MD, PhD         
Sponsors and Collaborators
Skane University Hospital
  More Information

No publications provided

Responsible Party: Bodil Ohlsson, MD, PhD, Department of Clinical Sciences
ClinicalTrials.gov Identifier: NCT01152047     History of Changes
Other Study ID Numbers: 2009/502, 2009/502
Study First Received: June 23, 2010
Last Updated: June 28, 2010
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Skane University Hospital:
oxytocin
satiety
dyspepsia

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014