Evaluation of Brain Opioid Receptor Activity in Anorexia Nervosa : a PET [11C]Diprenorphine Study

NCT ID: NCT02524301

Last Updated: 2018-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2016-07-29

Brief Summary

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The place of opioid system in anorexia nervosa (AN) physiopathology is still unclear. Conflicting results were published on cerebral spinal fluid or peripheral levels in anorexia nervosa. However, no data have been reported on opioid cerebral activity. Diprenorphine is a ligand with non-selective binding to opiate receptors µ, κ and δ capable to assess the interaction between endogenous opioids and their receptors.

Detailed Description

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Conditions

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Body Dysmorphic Disorders Anorexia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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anorexia nervosa patients

Cerebral \[11C\]diprenorphine Binding Potential measured by Positron emission Tomography (PET)

Group Type EXPERIMENTAL

Positron Emission Tomography using [11C]diprenorphine

Intervention Type DRUG

PET using \[11C\]diprenorphine

Recovered anorexia nervosa patients

Cerebral \[11C\]diprenorphine Binding Potential measured by Positron emission Tomography (PET)

Group Type EXPERIMENTAL

Positron Emission Tomography using [11C]diprenorphine

Intervention Type DRUG

PET using \[11C\]diprenorphine

Healthy Volonteers

Cerebral \[11C\]diprenorphine Binding Potential measured by Positron emission Tomography (PET)

Group Type EXPERIMENTAL

Positron Emission Tomography using [11C]diprenorphine

Intervention Type DRUG

PET using \[11C\]diprenorphine

Interventions

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Positron Emission Tomography using [11C]diprenorphine

PET using \[11C\]diprenorphine

Intervention Type DRUG

Other Intervention Names

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PET

Eligibility Criteria

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Inclusion Criteria

* AN patients DSM IV criteria including amenorrhea BMI \< 17.5 kg/m² and abnormal nutritional markers Group 1 (N=15) : long period of / recurrent weight loss (\> 2 yrs) Group 2 (N=15) : recent weight loss (6 to 12 months)
* Recovered AN patients History of AN Weight recovery and BMI \> 18.5 kg/m², stable for at least 12 months Normal nutritional markers Group 1 (N=15) : menses recovery after bodyweight stabilization Group 2 (N=15) : long persistence of amenorrhea (\> 12 months) despite weight recovery
* Healthy volunteers (N=15) BMI between 18.5 and 25 kg/m², normal nutritional markers, absence of psychiatric or organic pathology
* For all subjects Women 18-35 yrs Written and sign consent Affiliation to health insurance

Exclusion Criteria

* History of heart failure
* Psychotropic treatment , antiepileptics
* Ongoing or suspected pregnancy, positive beta HCG test before brain imaging
* Intense physical activity
* Constrains for MRI (ferromagnetic implants or claustrophobia)
* Refusal to be informed in case of incidentaloma revealed by brain imaging
* Refusal for written consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruno Estour, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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CHU Clermont Ferrand

Clermont-Ferrand, , France

Site Status

CNRH

Clermont-Ferrand, , France

Site Status

CHU Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

References

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Galusca B, Traverse B, Costes N, Massoubre C, Le Bars D, Estour B, Germain N, Redoute J. Decreased cerebral opioid receptors availability related to hormonal and psychometric profile in restrictive-type anorexia nervosa. Psychoneuroendocrinology. 2020 Aug;118:104711. doi: 10.1016/j.psyneuen.2020.104711. Epub 2020 May 19.

Reference Type DERIVED
PMID: 32460196 (View on PubMed)

Other Identifiers

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0908019

Identifier Type: -

Identifier Source: org_study_id

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