Ghrelin With Anorexia Nervosa | NCT00825461

Studies
Ghrelin With Anorexia Nervosa

NCT00825461

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

Jan 9, 2018Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Anorexia Nervosa

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009Actual

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 31, 2012Actual

First Submitted Date

Jan 20, 2009

First Submission Date that Met QC Criteria

Jan 20, 2009

First Posted Date

Jan 21, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2018

Last Update Posted Date

Jan 9, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Anorexia with tube feeding
2		Anorexia without tube feeding
3		Control

Interventions

Not provided

Measure	Description	Time Frame
Concentration of ghrelin in blood.		1 morning

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

35 Years

Standard Ages

ChildAdult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martine F Delfos, Dr	PICOWO Utrecht	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Maastricht		Maastricht	Limburg	6202 AZ	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	Bosse, T.; Delfos., M.F.; Jonker, C.M. & Treur, J. (2003). Reasoning about adaptive Dynamical Systems in the Analysis of eating Regulation Disorders. N.J. Mahwah. Proceedings of the 25th Annual Conference of the Cognitive Science Society. Lawrence Erlbaum Associates Inc.
	Background	Both, F. & Delfos, M.F. (in preparation). The role of ghrelin in eating disorders, a review.

ID	Term
D001068	Feeding and Eating Disorders
D001523	Mental Disorders