NCT00493519

Brief Summary

The objective of this trial is to examine the cephalic phase insulin response (CPIR) and pancreatic polypeptide (PP) release as indicators of the cephalic phase occurrence and magnitude to palatable food stimulus in anorectic and bulimic subgroups as compared to healthy controls

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2007

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

July 6, 2007

Status Verified

April 1, 2007

First QC Date

June 27, 2007

Last Update Submit

July 4, 2007

Conditions

Anorexia NervosaBulimia Nervosa

Keywords

Cephalic phaseAnorexia nervosaBulimia nervosaobese binge eatersVASEDIshame-feed procedure

Outcome Measures

Primary Outcomes (1)

  • VAS, EDI, Blood test for glucose, insulin, PP, shame feed procedure

    1 year

Interventions

chocolate cakePROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients will be divided into the following 4 subgroups;
  • patients with anorexia nervosa.
  • patients with bulimia nervosa (purging type).
  • patients with binge eating disorder and obesity.
  • obese patients without eating disorder
  • Non-eating disordered normal weight patients.
  • Non diabetic and non-pregnant patients above 18 years of age without gastrointestinal diseases and without medications which can affect gastrointestinal motility and appetite.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TASMC

Tel Aviv, 64239, Israel

RECRUITING

MeSH Terms

Conditions

Anorexia NervosaBulimia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Nachum Vaisman, Prof.

    TASMC Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nachum Vaisman, Prof.

CONTACT

+972-524-266596vaisman@tasmc.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 27, 2007

First Posted

June 28, 2007

Study Start

July 1, 2007

Study Completion

December 1, 2007

Last Updated

July 6, 2007

Record last verified: 2007-04

Locations

IL(1)