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NCT04451759 Clinical Trial

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

Eating Disorders Clinical Trial

— HYPOTHALNET  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04451759
Other study ID # 2019-45
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 25, 2020
Est. completion date December 15, 2021

Study information
Verified date June 2020
Source Assistance Publique Hopitaux De Marseille
Contact Maxime Guye, MD
Email maxime.guye@ap-hm.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 66
Est. completion date December 15, 2021
Est. primary completion date September 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• MRI exploration
ultra high field (7T) magnetic resonance imaging

Locations
Country Name City State
France Assistance Publique Hôpitaux de Marseille Marseille

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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