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

NCT ID: NCT02995226

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-27
• Study Completion Date: 2020-09-30

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.

Conditions

Anorexia Nervosa

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Anorexia nervosa

Patients with DSM-5 criteria of "anorexia nervosa"

Group Type: OTHER

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

Intervention Type: OTHER

Clinical and biological examination, Saliva (or blood) test, glycemia, thermal test, cognitive and bike tests, questionnaires

First degree relatives

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

Group Type: OTHER

Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires

Intervention Type: OTHER

Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires

Controls (with no eating disorder)

Other

Group Type: OTHER

Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires

Intervention Type: OTHER

Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier St Anne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip GORWOOD, MD, PhD

Role: STUDY_CHAIR

CHSA

Locations

Centre Hospitalier Sainte Anne

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Philip GORWOOD, MD, PhD

Role: CONTACT

p.gorwood@ch-sainte-anne.fr

00 33 45 65 86 39

Marie GODARD

Role: CONTACT

s.dorocant@ch-sainte-anne.fr

00 33 1 45 65 77 28

Facility Contacts

Philip GORWOOD, MD., PhD

Role: primary

p.gorwood@ch-sainte-anne.fr

0033 1 45 65 86 39

Sylvie DOROCANT

Role: backup

s.dorocant@ch-sainte-anne.fr

0033 1 45 65 77 28

Other Identifiers

D15-P018

Identifier Type: -

Identifier Source: org_study_id