Anorexia NervosaCAPANOXNCT02995226
Abnormal Regulation, Estimation and Cognitive Impacts of Physical Efforts as an Endophenotype of Anorexia Nervosa
A study testing Clinical and biological examination, Saliva (or blood) test Glycemia, thermal test, cognitive and bike tests, questionnaires and Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires in people with Anorexia Nervosa, run by Centre Hospitalier St Anne at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Clinical and biological examination, Saliva (or blood) test Glycemia, thermal test, cognitive and bike tests, questionnaires and Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2017to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Show all 17Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Sainte Anne
Paris, 75014
Philip GORWOOD, MD., PhD, 0033 1 45 65 86 39, p.gorwood@ch-sainte-anne.fr
Sylvie DOROCANT, 0033 1 45 65 77 28, s.dorocant@ch-sainte-anne.fr
About this study
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
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.
Read the 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
- Being tested
- 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
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and biological examination, Saliva (or blood) test Glycemia, thermal test, cognitive and bike tests, questionnairesOther
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, questionnairesOther
Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Anorexia nervosa | Other | Patients with DSM-5 criteria of "anorexia nervosa" Receives: Other: Clinical and biological examination, Saliva (or blood) test Glycemia, thermal test, cognitive and bike tests, questionnaires |
| First degree relatives | Other | First degree relatives (of patients suffering from anorexia nervosa) with no eating disorder Receives: Other: Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires |
| Controls (with no eating disorder) | Other | Other Receives: Other: Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical power
Comparison inter and intra individual of the subjective and objective power to the subjects during a typical physical bike test.
Measured: Day 0
Secondary outcomes (8)
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
Measured: Day 0
Wellbeing self-questionnaire
Comparison before and after bike test
Measured: Day 0
Hunger Visual analogical scale
Comparison before and after bike test
Measured: Day 0
PANAS score (self-questionnaire)
Emotions. Comparison before and after bike test
Measured: Day 0
Hunger Visual analogical scale
Apetite. Comparison before and after bike test
Measured: Day 0
Performance on the Briton cognitive test (number of errors)
Mental flexibility. Comparison before and after bike test
Measured: 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.
Measured: 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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study start27 Feb 2017
- Primary completionApr 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip GORWOOD, MD, PhD, Study chair, CHSA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995226
- Sponsor's protocol ID
- D15-P018
- Acronym
- CAPANOX
- Status last verified
- Jan 2018
- First submitted
- 5 Dec 2016
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02995226
- Acronym / sponsor ID
- CAPANOX / D15-P018
- Conditions
- Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 16 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anorexia nervosa | Other | Other: Clinical and biological examination, Saliva (or blood) test Glycemia, thermal test, cognitive and bike tests, questionnairesPatients with DSM-5 criteria of "anorexia nervosa" |
| First degree relatives | Other | Other: Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnairesFirst degree relatives (of patients suffering from anorexia nervosa) with no eating disorder |
| Controls (with no eating disorder) | Other | Other: Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnairesOther |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
- Diagnosis of ED (eating disorders) in the EDI-2 and in the MINI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical and biological examination, Saliva (or blood) test Glycemia, thermal test, cognitive and bike tests, questionnairesClinical and biological examination, Saliva (or blood) test, glycemia, thermal test, cognitive and bike tests, questionnaires | Other | Anorexia nervosa |
| Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnairesClinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires | Other | Controls (with no eating disorder), First degree relatives |
Primary outcome
Physical power
Time frame: Day 0
Comparison inter and intra individual of the subjective and objective power to the subjects during a typical physical bike test.
8 secondary outcomes
Pain threshold
Time frame: Day 0
Wellbeing self-questionnaire
Time frame: Day 0
Hunger Visual analogical scale
Time frame: Day 0
PANAS score (self-questionnaire)
Time frame: Day 0
Hunger Visual analogical scale
Time frame: Day 0
Performance on the Briton cognitive test (number of errors)
Time frame: Day 0
Performance on cognitive tests (speed, number of errors), before versus after the exercise, in the three groups.
Time frame: Day 0
Genetical analysis
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip GORWOOD, MD, PhD study chair
CHSA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical and biological examination, Saliva (or blood) test Glycemia, thermal test, cognitive and bike tests, questionnaires and Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires in people with Anorexia Nervosa, run by Centre Hospitalier St Anne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philip GORWOOD, MD, PhD (00 33 45 65 86 39, p.gorwood@ch-sainte-anne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical power (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.