Study on Brain Function of Obesity Classification

NCT ID: NCT05892224

Last Updated: 2023-06-07

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

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2025-12-31

Brief Summary

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The purpose of this study was to investigate the differences and similarities of brain function in patients with four subtypes of obesity, and the relationship between brain function changes and complications after weight loss and metabolic improvement. 120 patients with obesity and 30 healthy individuals with normal BMI were enrolled.

Detailed Description

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Although the investigators have clinically observed significant differences in appetite and metabolic status in patients with the above four types of obesity, the brain functional characteristics of different obesity subtypes and their relationship with metabolic markers are still unclear. Based on this, in this project, the investigators plan to explore further the similarities and differences in brain function in patients with four subtypes of obesity and the relationship between brain function changes after weight loss and metabolic improvement and the occurrence of complications.

120 patients with obesity and 30 healthy individuals with normal BMI were enrolled.

All patients with obesity underwent LSG. A multidisciplinary team evaluated participants with obesity at baseline, 1, 3, 6, and 12 months after laparoscopic sleeve gastrectomy (LSG). Anthropometrics, Metabolic indicators, sex hormones, menstruation,glucose-lipid metabolic markers, and hepatic steatosis assessed by FibroScan(CAP value and E value) were measured baseline and postoperative. Resting and task state functional magnetic resonance imaging (fMRI) measurements were performed at baseline for all participants at two-time points before and after meals. Measurements were repeated in obese patients 6 months after surgery.

Conditions

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Obesity Functional Neuroimaging

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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MHO group

Metabolic healthy obesity

Laparoscopic sleeve gastrectomy

Intervention Type PROCEDURE

Obese patients of different subtypes were all expected to undergo bariatric surgery

HMO-U group

Hypermetabolic obesity-hyperuricemia

Laparoscopic sleeve gastrectomy

Intervention Type PROCEDURE

Obese patients of different subtypes were all expected to undergo bariatric surgery

HMO-I group

Hypermetabolic obesity-hyperinsulinemia

Laparoscopic sleeve gastrectomy

Intervention Type PROCEDURE

Obese patients of different subtypes were all expected to undergo bariatric surgery

LMO group

Hypometabolic obesity

Laparoscopic sleeve gastrectomy

Intervention Type PROCEDURE

Obese patients of different subtypes were all expected to undergo bariatric surgery

control group

Healthy person

No interventions assigned to this group

Interventions

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Laparoscopic sleeve gastrectomy

Obese patients of different subtypes were all expected to undergo bariatric surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age ranged from 16-65 years old
* BMI over 37.5kg/m2, or BMI over 32.5kg/m2 with diabetes which meets the recommended cut-off bariatric surgery of the Guidelines for surgical treatment of obesity accompanied with or without type 2 diabetes in China.

Exclusion Criteria

* secondary causes of obesity such as hypothalamic obesity, Cushing syndrome, hypophysis dysfunction, etc
* pregnancy or location
* contraindications for laparoscopic surgery, such as gastrointestinal diseases of intra-abdominal infection, adhesion, etc
* severe heart, liver, and kidney dysfunction
* organic and systemic diseases intolerant of surgery.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shen Qu

Clinical Professor and Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shen Qu, Dr.

Role: STUDY_CHAIR

Shanghai 10th People's Hospital

Locations

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Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shen Qu, Dr.

Role: CONTACT

(86)021-66301004

Facility Contacts

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Shen Qu, M.D. Ph.D

Role: primary

86-21-66302531

Other Identifiers

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Brain function in obesity

Identifier Type: -

Identifier Source: org_study_id

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