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Ghrelin With Anorexia Nervosa
This study is not yet open for participant recruitment.
Verified by Maastricht University Medical Center, January 2009
First Received: January 20, 2009   No Changes Posted
Sponsored by: Maastricht University Medical Center
Information provided by: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00825461
  Purpose

The PICOWO research group in corporation with the University of Amsterdam (Artificial Intelligence) has developed a computer simulationmodel of eating disorders (Bosse, Delfos, Jonker & Treur, 2003). In a running Phd project we want to add ghrelin to the model. The idea for this current research is to collect clinical information about the functioning and (patho)physiology of ghrelin in patients with AN, so we can extend the simulation.


Condition
Anorexia Nervosa

Drug Information available for: Ghrelin
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: Level of Ghrelin With Anorexia Nervosa (AN) Patients. Subgroup AN: With and Without Tubefeeding.

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Concentration of ghrelin in blood. [ Time Frame: 1 morning ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Whole blood


Estimated Enrollment: 20
Study Start Date: March 2009
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Anorexia with tube feeding
2
Anorexia without tube feeding
3
Control

Detailed Description:

Eating disorders are in need of new perspectives. A better understanding of the appetite in patients with eating disorders, especially Anorexia Nervosa, could be investigated by the levels of ghrelin in patients with and without tube feeding.

  Eligibility

Ages Eligible for Study:   12 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Studypopulation: Patiënts: all female, non -age coupled. Subgroup patients without tube feeding, with tube feeding and a healthy matched control group.

Control group: healthy volunteers of the University of Maastricht.

Criteria

Inclusion Criteria:

  • Studypopulation: Patiënts: all female, non -age coupled.
  • Subgroup patients without tube feeding, with tube feeding and a healthy matched control group.
  • Control group: healty volunteers of the University of Maastricht.

Exclusion Criteria:

  • Patients with a history of eating disorder different than AN or a psychiatric history.
  • Control group: no history of eating disorders or other psychiatric disabilities. Normal physical examination, ecg, laboratorium (blood cells, liver, kidneys)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00825461

Locations
Netherlands, Limburg
University Hospital Maastricht
Maastricht, Limburg, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Martine F Delfos, Dr PICOWO Utrecht
  More Information

No publications provided

Responsible Party: PICOWO ( Dr MF Delfos )
Study ID Numbers: 08-3-089
Study First Received: January 20, 2009
Last Updated: January 20, 2009
ClinicalTrials.gov Identifier: NCT00825461     History of Changes
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Anorexia Nervosa

Study placed in the following topic categories:
Signs and Symptoms
Signs and Symptoms, Digestive
Mental Disorders
Anorexia
Anorexia Nervosa
Eating Disorders

Additional relevant MeSH terms:
Signs and Symptoms
Signs and Symptoms, Digestive
Mental Disorders
Anorexia
Anorexia Nervosa
Eating Disorders

ClinicalTrials.gov processed this record on May 07, 2009