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

October 26, 2018 updated by: Centre Hospitalier Universitaire de Saint Etienne
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France
        • CHU Clermont Ferrand
      • Clermont-Ferrand, France
        • CNRH
      • Saint-Etienne, France, 42055
        • CHU Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: anorexia nervosa patients
Cerebral [11C]diprenorphine Binding Potential measured by Positron emission Tomography (PET)
Drug: Positron Emission Tomography using [11C]diprenorphine
PET using [11C]diprenorphine
Other Names:
  • PET
Experimental: Recovered anorexia nervosa patients
Cerebral [11C]diprenorphine Binding Potential measured by Positron emission Tomography (PET)
Drug: Positron Emission Tomography using [11C]diprenorphine
PET using [11C]diprenorphine
Other Names:
  • PET
Experimental: Healthy Volonteers
Cerebral [11C]diprenorphine Binding Potential measured by Positron emission Tomography (PET)
Drug: Positron Emission Tomography using [11C]diprenorphine
PET using [11C]diprenorphine
Other Names:
  • PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
[11C]diprenorphine binding potential
Time Frame: week 2
Value of [11C]diprenorphine binding potential (BP) in predefined brains regions [11C] diprenorphine BP will be evaluated by brain positron emission tomography
week 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation [11C]diprenorphine binding potential
Time Frame: week 2
Correlation between [11C]diprenorphine binding potential and plasma endogenous opioid levels
week 2
Correlation [11C]diprenorphine binding potential
Time Frame: week 2
Correlation between [11C]diprenorphine binding potential and psychometric score evaluating addictive behavior, reward and positive reinforcement
week 2
Correlation [11C]diprenorphine binding potential
Time Frame: week 2
Correlation between [11C]diprenorphine binding potential and appetite regulating hormones
week 2
Correlation [11C]diprenorphine binding potential
Time Frame: week 2
Correlation between [11C]diprenorphine binding potential and LH response during GnRH test
week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Ministry of Health, France

Investigators

  • Principal Investigator: Bruno Estour, PhD, CHU Saint-Etienne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2009

Primary Completion (Actual)

July 28, 2016

Study Completion (Actual)

July 29, 2016

Study Registration Dates

First Submitted

August 12, 2015

First Submitted That Met QC Criteria

August 13, 2015

First Posted (Estimate)

August 14, 2015

Study Record Updates

Last Update Posted (Actual)

October 29, 2018

Last Update Submitted That Met QC Criteria

October 26, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0908019

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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