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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02995226
Acronym
CAPANOX
Enrollment
180
Registered
2016-12-16
Start date
2017-02-27
Completion date
2020-09-30
Last updated
2018-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia Nervosa

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.

Interventions

OTHERClinical 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

OTHERClinical 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

Sponsors

Centre Hospitalier St Anne
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Physical powerDay 0Comparison inter and intra individual of the subjective and objective power to the subjects during a typical physical bike test.

Secondary

MeasureTime frameDescription
Wellbeing self-questionnaireDay 0Comparison before and after bike test
Hunger Visual analogical scaleDay 0Comparison before and after bike test
PANAS score (self-questionnaire)Day 0Emotions. Comparison before and after bike test
Pain thresholdDay 0This 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
Performance on cognitive tests (speed, number of errors), before versus after the exercise, in the three groups.Day 0Tests. Performance on cognitive tests (speed, number of errors), before versus after the exercise, in the three groups.
Genetical analysisDay 010 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.
Performance on the Briton cognitive test (number of errors)Day 0Mental flexibility. Comparison before and after bike test

Countries

France

Contacts

Primary ContactPhilip GORWOOD, MD, PhD
p.gorwood@ch-sainte-anne.fr00 33 45 65 86 39
Backup ContactMarie GODARD
s.dorocant@ch-sainte-anne.fr00 33 1 45 65 77 28

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026