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Abnormal Regulation, Estimation and Cognitive Impacts of Physical Efforts as an Endophenotype of Anorexia Nervosa (CAPANOX)

Primary Purpose

Anorexia Nervosa

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Clinical and biological examination, Saliva (or blood) test Glycemia, thermal test, cognitive and bike tests, questionnaires
Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires
Sponsored by
Centre Hospitalier St Anne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anorexia Nervosa

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Patients :

  • Woman
  • 18 - 50 years
  • eating disorders (with or without bulimia) according to the EDI-2 (Eating Disorder Inventory) and the MINI (Mini International Neuropsychiatric Interview)
  • BMI (Body Mass index) between 14 and 17,5
  • first degree relative without ED (eating disorders)

First degree relatives :

  • Woman
  • 18 - 50 years
  • Mother or sister of patient with eating disorders
  • BMI (Body Mass index) upper to 17,5
  • Healthy of all ED (eating disorders)

Controls :

  • Woman
  • 18 - 50 years
  • BMI > 17,5
  • Without ED (eating disorders)

Exclusion Criteria:

All groups :

  • Contraindication in the practice of an intensive sport
  • Cardiovascular Family history with risk of cardiovascular unwanted events
  • Cardiovascular, surgical personal Histories, ostéoarticulaires or musculo-tendinous against indicating to the practice of a sport
  • Intercurrents psychiatric pathologies (humor or psychotics disorders, chronic or acute)

Related and controls :

Diagnosis of ED (eating disorders) in the EDI-2 and in the MINI

Sites / Locations

  • Centre Hospitalier Sainte AnneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Anorexia nervosa

First degree relatives

Controls (with no eating disorder)

Arm Description

Patients with DSM-5 criteria of "anorexia nervosa"

First degree relatives (of patients suffering from anorexia nervosa) with no eating disorder

Other

Outcomes

Primary Outcome Measures

Physical power
Comparison inter and intra individual of the subjective and objective power to the subjects during a typical physical bike test.

Secondary Outcome Measures

Pain threshold
This threshold is based on the minimum temperature that the patient is able to suppor (the probe is placed on the skin of the forarm, and the temperature reduces its temperature every 10 seconds), knowing that the machine is not getting to temperatures that can be damageable. Comparison before and after bike test
Wellbeing self-questionnaire
Comparison before and after bike test
Hunger Visual analogical scale
Comparison before and after bike test
PANAS score (self-questionnaire)
Emotions. Comparison before and after bike test
Hunger Visual analogical scale
Apetite. Comparison before and after bike test
Performance on the Briton cognitive test (number of errors)
Mental flexibility. Comparison before and after bike test
Performance on cognitive tests (speed, number of errors), before versus after the exercise, in the three groups.
Tests. Performance on cognitive tests (speed, number of errors), before versus after the exercise, in the three groups.
Genetical analysis
10 candidate genes will be analyzed (following the collection of blood or saliva) assessing the frequency of their main alleles (variants), looking for a significant difference of allele frequency between the 3 groups.

Full Information

First Posted
December 5, 2016
Last Updated
January 23, 2018
Sponsor
Centre Hospitalier St Anne
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1. Study Identification

Unique Protocol Identification Number
NCT02995226
Brief Title
Abnormal Regulation, Estimation and Cognitive Impacts of Physical Efforts as an Endophenotype of Anorexia Nervosa
Acronym
CAPANOX
Official Title
Analysis of the Capacity to Regulate Physical Efforts and to Estimate Its Intensity as an Endophenotype of Anorexia Nervosa, Because of a Specific Impact of the Physical Effort at the Emotional, Cognitive, Pain, Genetic and Biological Level
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 27, 2017 (Actual)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier St Anne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to check if patients, but also relatives (as they share familial and genetic risk factors), are having more difficulties in regulating a spontaneous, pleasant physical effort (doing "too much") compared to healthy controls, and if physical efforts are participating to core symptoms of anorexia nervosa, such as more appetite (instead of less), less pain, more abnormal body image, and less cognitive flexibility. Such a result could help to further understand the role of difficulties with physical exercise as part of the phenotype of anorexia nervosa.
Detailed Description
This is a three steps protocol. First, patients (with anorexia nervosa), controls (with no eating disorder) and first degree relatives (with no eating disorder) will be tested for emotional accuracy (seing faces on a screen with different core emotions), pain threshold (how long they can support a cold probe), body size (how they see themselves), appetite and cognitive flexibility (a test where the capacity to change rules during a game is done easily or not). Then all subjects will do a standardized physical exercise which represents an effort with the equivalent level of energy for each participants as being chosen according to each level of competency (assessed through the "maximal aerobic power"). The third step consists in the repetition of (nearly) initial tests.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anorexia nervosa
Arm Type
Other
Arm Description
Patients with DSM-5 criteria of "anorexia nervosa"
Arm Title
First degree relatives
Arm Type
Other
Arm Description
First degree relatives (of patients suffering from anorexia nervosa) with no eating disorder
Arm Title
Controls (with no eating disorder)
Arm Type
Other
Arm Description
Other
Intervention Type
Other
Intervention Name(s)
Clinical and biological examination, Saliva (or blood) test Glycemia, thermal test, cognitive and bike tests, questionnaires
Intervention Description
Clinical and biological examination, Saliva (or blood) test, glycemia, thermal test, cognitive and bike tests, questionnaires
Intervention Type
Other
Intervention Name(s)
Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires
Intervention Description
Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires
Primary Outcome Measure Information:
Title
Physical power
Description
Comparison inter and intra individual of the subjective and objective power to the subjects during a typical physical bike test.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Pain threshold
Description
This threshold is based on the minimum temperature that the patient is able to suppor (the probe is placed on the skin of the forarm, and the temperature reduces its temperature every 10 seconds), knowing that the machine is not getting to temperatures that can be damageable. Comparison before and after bike test
Time Frame
Day 0
Title
Wellbeing self-questionnaire
Description
Comparison before and after bike test
Time Frame
Day 0
Title
Hunger Visual analogical scale
Description
Comparison before and after bike test
Time Frame
Day 0
Title
PANAS score (self-questionnaire)
Description
Emotions. Comparison before and after bike test
Time Frame
Day 0
Title
Hunger Visual analogical scale
Description
Apetite. Comparison before and after bike test
Time Frame
Day 0
Title
Performance on the Briton cognitive test (number of errors)
Description
Mental flexibility. Comparison before and after bike test
Time Frame
Day 0
Title
Performance on cognitive tests (speed, number of errors), before versus after the exercise, in the three groups.
Description
Tests. Performance on cognitive tests (speed, number of errors), before versus after the exercise, in the three groups.
Time Frame
Day 0
Title
Genetical analysis
Description
10 candidate genes will be analyzed (following the collection of blood or saliva) assessing the frequency of their main alleles (variants), looking for a significant difference of allele frequency between the 3 groups.
Time Frame
Day 0

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients : Woman 18 - 50 years eating disorders (with or without bulimia) according to the EDI-2 (Eating Disorder Inventory) and the MINI (Mini International Neuropsychiatric Interview) BMI (Body Mass index) between 14 and 17,5 first degree relative without ED (eating disorders) First degree relatives : Woman 18 - 50 years Mother or sister of patient with eating disorders BMI (Body Mass index) upper to 17,5 Healthy of all ED (eating disorders) Controls : Woman 18 - 50 years BMI > 17,5 Without ED (eating disorders) Exclusion Criteria: All groups : Contraindication in the practice of an intensive sport Cardiovascular Family history with risk of cardiovascular unwanted events Cardiovascular, surgical personal Histories, ostéoarticulaires or musculo-tendinous against indicating to the practice of a sport Intercurrents psychiatric pathologies (humor or psychotics disorders, chronic or acute) Related and controls : Diagnosis of ED (eating disorders) in the EDI-2 and in the MINI
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip GORWOOD, MD, PhD
Phone
00 33 45 65 86 39
Email
p.gorwood@ch-sainte-anne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marie GODARD
Phone
00 33 1 45 65 77 28
Email
s.dorocant@ch-sainte-anne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip GORWOOD, MD, PhD
Organizational Affiliation
CHSA
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Hospitalier Sainte Anne
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip GORWOOD, MD., PhD
Phone
0033 1 45 65 86 39
Email
p.gorwood@ch-sainte-anne.fr
First Name & Middle Initial & Last Name & Degree
Sylvie DOROCANT
Phone
0033 1 45 65 77 28
Email
s.dorocant@ch-sainte-anne.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Abnormal Regulation, Estimation and Cognitive Impacts of Physical Efforts as an Endophenotype of Anorexia Nervosa

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