NCT04451759

Brief Summary

Food intake is a motivated behaviour that consists of seeking, selecting and ingesting nutritional resources from the environment. Its main function is therefore, depending on these conditions, to ensure the supply, in adequate quantities, of the energy and biochemical substrates necessary for the proper functioning and need of the body. Thus, in addition to maintaining the body's fat mass level stable, dietary behaviour is part of the energy homeostasis system and is thus regulated and maintained by the central nervous system. Although diet regulation involves several brain regions, the way in which these different regions communicate with each other and influence each other to orchestrate appropriate eating behaviour is not yet fully characterized. Among the structures of this network, the hypothalamus, a small structure (less than 1 cm3 in humans) composed of several nuclei such as the lateral hypothalamus, the arched nucleus or the lateral tuberal nucleus plays a crucial role. The investigators propose to use ultra high field (7T) magnetic resonance imaging equiping the CEMEREM (CHU Timone, APHM, Marseille) to better characterize the role of this crucial small structure in food intake networks in order to better understand the impact of these structural and functional disorders observed in patients with anorexia nervosa and obesity compared to a control population without eating behaviour disorders.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

June 25, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
Last Updated

July 9, 2020

Status Verified

June 1, 2020

Enrollment Period

1.2 years

First QC Date

June 22, 2020

Last Update Submit

July 8, 2020

Conditions

Eating Disorders

Outcome Measures

Primary Outcomes (1)

  • MRI exploration conducted at 7T

    Mapping of MRI parameters of 4 sub-regions of the hypothalamus, in order to determine whether the sensitivity of quantitative T1 to 7T imaging at very high resolution can reveal microstructure variations in the 4 sub-regions of the hypothalamus in patients suffering from obesity or anorexia nervosa compared to a control population without eating disorders.

    2 years

Study Arms (3)

healthy controls

ACTIVE COMPARATOR
Other: MRI exploration

Anorexia

EXPERIMENTAL
Other: MRI exploration

Obesity

EXPERIMENTAL
Other: MRI exploration

Interventions

MRI explorationOTHER

ultra high field (7T) magnetic resonance imaging

AnorexiaObesityhealthy controls

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No depression (HADS and BECK scores)
  • No contraindication to 7T MRI
  • Subject with with social insurance
  • Subject who has signed the informed consent
  • For obese patients
  • Body mass index \> 30kg/m2
  • Body diameter \< 60cm (compatible with 7T MR scanner tube)
  • For anorexic patients
  • mental anorexia according to DMS-V
  • Body mass index \< 17kg/m2
  • For healthy controls
  • kg/m2\<Body mass index \< 25kg/m2
  • no feeding behavioral disturbance (SCOFF and EAT 26)

You may not qualify if:

  • Pregnant or parturiente woman
  • subject with other neurological or neuropsychiatric diseases
  • subject with addiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13005, France

RECRUITING

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Jean Olivier ARNAUD

    Assistance Publique Hôpitaux de Marseille

    STUDY DIRECTOR

Central Study Contacts

Maxime Guye, MD

CONTACT

maxime.guye@ap-hm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2020

First Posted

June 30, 2020

Study Start

June 25, 2020

Primary Completion

September 15, 2021

Study Completion

December 15, 2021

Last Updated

July 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)