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

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

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.

Study Overview

• Status: Unknown
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Other: Clinical and biological examination, Saliva (or blood) test Glycemia, thermal test, cognitive and bike tests, questionnaires; Other: Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires

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.

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philip GORWOOD, MD, PhD; Phone Number: 00 33 45 65 86 39; Email: p.gorwood@ch-sainte-anne.fr
• Study Contact Backup: Name: Marie GODARD; Phone Number: 00 33 1 45 65 77 28; Email: s.dorocant@ch-sainte-anne.fr

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • Centre hospitalier Sainte Anne
    • Contact: Philip GORWOOD, MD., PhD; Phone Number: 0033 1 45 65 86 39; Email: p.gorwood@ch-sainte-anne.fr
    • Contact: Sylvie DOROCANT; Phone Number: 0033 1 45 65 77 28; Email: s.dorocant@ch-sainte-anne.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Anorexia nervosa; Patients with DSM-5 criteria of "anorexia nervosa"	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
Other: First degree relatives; First degree relatives (of patients suffering from anorexia nervosa) with no eating disorder	Other: 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
Other: Controls (with no eating disorder); Other	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Wellbeing self-questionnaire	Comparison before and after bike test	Day 0
Hunger Visual analogical scale	Comparison before and after bike test	Day 0
PANAS score (self-questionnaire)	Emotions. Comparison before and after bike test	Day 0
Hunger Visual analogical scale	Apetite. Comparison before and after bike test	Day 0
Performance on the Briton cognitive test (number of errors)	Mental flexibility. Comparison before and after bike test	Day 0
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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier St Anne
• Investigators: Study Chair: Philip GORWOOD, MD, PhD, CHSA

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2017
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: December 5, 2016
• First Submitted That Met QC Criteria: December 13, 2016
• First Posted (Estimate): December 16, 2016

Study Record Updates

• Last Update Posted (Actual): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: D15-P018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No