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Study on Brain Function of Obesity Classification

T

Tongji University

Status

Enrolling

Conditions

Obesity
Functional Neuroimaging

Treatments

Procedure: Laparoscopic sleeve gastrectomy

Study type

Observational

Funder types

Other

Identifiers

NCT05892224
Brain function in obesity

Details and patient eligibility

About

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.

Full description

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.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

150 participants in 5 patient groups

MHO group
Description:
Metabolic healthy obesity
Treatment:
Procedure: Laparoscopic sleeve gastrectomy
HMO-U group
Description:
Hypermetabolic obesity-hyperuricemia
Treatment:
Procedure: Laparoscopic sleeve gastrectomy
HMO-I group
Description:
Hypermetabolic obesity-hyperinsulinemia
Treatment:
Procedure: Laparoscopic sleeve gastrectomy
LMO group
Description:
Hypometabolic obesity
Treatment:
Procedure: Laparoscopic sleeve gastrectomy
control group
Description:
Healthy person

Trial contacts and locations

1

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Central trial contact

Shen Qu, Dr.

Data sourced from clinicaltrials.gov

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