search
Back to results

Exploration by UHF MRI of Hypothalamic Networks Associated to Feeding in Obesity and Anorexia (HYPOTHALNET)

Primary Purpose

Eating Disorders

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI exploration
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Eating Disorders

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

  • 18.5kg/m2<Body mass index < 25kg/m2
  • no feeding behavioral disturbance (SCOFF and EAT 26)

Exclusion Criteria:

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

Sites / Locations

  • Assistance Publique Hôpitaux de MarseilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

healthy controls

Anorexia

Obesity

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 22, 2020
Last Updated
July 8, 2020
Sponsor
Assistance Publique Hopitaux De Marseille
search

1. Study Identification

Unique Protocol Identification Number
NCT04451759
Brief Title
Exploration by UHF MRI of Hypothalamic Networks Associated to Feeding in Obesity and Anorexia
Acronym
HYPOTHALNET
Official Title
Exploration by UHF MRI of Hypothalamic Networks Associated to Feeding in Obesity and Anorexia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 25, 2020 (Actual)
Primary Completion Date
September 15, 2021 (Anticipated)
Study Completion Date
December 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
healthy controls
Arm Type
Active Comparator
Arm Title
Anorexia
Arm Type
Experimental
Arm Title
Obesity
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
MRI exploration
Intervention Description
ultra high field (7T) magnetic resonance imaging
Primary Outcome Measure Information:
Title
MRI exploration conducted at 7T
Description
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.
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 18.5kg/m2<Body mass index < 25kg/m2 no feeding behavioral disturbance (SCOFF and EAT 26) Exclusion Criteria: Pregnant or parturiente woman subject with other neurological or neuropsychiatric diseases subject with addiction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maxime Guye, MD
Email
maxime.guye@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Olivier ARNAUD
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxime Guye, MD
Email
maxime.guye@ap-hm.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Exploration by UHF MRI of Hypothalamic Networks Associated to Feeding in Obesity and Anorexia

We'll reach out to this number within 24 hrs