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

Anorexia Nervosa Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02995226
• Other study ID #: D15-P018
• Status: Recruiting
• Phase: N/A
• First received: December 5, 2016
• Last updated: January 23, 2018
• Start date: February 27, 2017
• Est. completion date: September 2020

Study information

• Verified date: January 2018
• Source: Centre Hospitalier St Anne
• Contact: Philip GORWOOD, MD, PhD
• Phone: 00 33 45 65 86 39
• Email: p.gorwood[@]ch-sainte-anne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: September 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Other:
• Clinical and biological examination, Saliva (or blood) test Glycemia, thermal test, cognitive and bike tests, questionnaires
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
Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires

Locations

Country	Name	City	State
France	Centre Hospitalier Sainte Anne	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier St Anne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical power	Comparison inter and intra individual of the subjective and objective power to the subjects during a typical physical bike test.	Day 0
Secondary	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	Day 0
Secondary	Wellbeing self-questionnaire	Comparison before and after bike test	Day 0
Secondary	Hunger Visual analogical scale	Comparison before and after bike test	Day 0
Secondary	PANAS score (self-questionnaire)	Emotions. Comparison before and after bike test	Day 0
Secondary	Hunger Visual analogical scale	Apetite. Comparison before and after bike test	Day 0
Secondary	Performance on the Briton cognitive test (number of errors)	Mental flexibility. Comparison before and after bike test	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0