NCT05892224

Brief Summary

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.

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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 7, 2023

Status Verified

May 1, 2023

Enrollment Period

4 years

First QC Date

March 10, 2023

Last Update Submit

May 27, 2023

Conditions

ObesityFunctional Neuroimaging

Keywords

obesityFunctional NeuroimagingBrainartificial intelligence

Outcome Measures

Primary Outcomes (1)

  • Functional magnetic resonance imaging of brain

    The subjects underwent fMRI scans before and after eating. Blood oxygen levels depend on functional brain imaging (Blod-fMRI) to collect the brain's local BLOD response (hemodynamic response) caused by the electrical activity of neurons. The stronger the BLOD response, the more excitability of the local brain. A region-of-interest (ROI) approach was applied with the use of masks that were established in an independent study of normal-weight subjects to be markers of satiety or predictors of food choices. ROIs included the left and right ventral striatum (nucleus accumbens), the left and right amygdala, the left and right dorsal striatum (caudate and putamen), the left and right insula, and the medial orbital frontal cortex (mOFC). functional connectivity analysis analyzes the compatibity of temporal signals of two or more pairs of brain regions or the differences in the strength of functional connections under different experimental conditions

    6 months

Secondary Outcomes (33)

  • BMI

    12 months

  • Waist/hip Ratio

    12 months

  • DXA(dual energy x-ray absorptiometry)

    12 months

  • Abdominal Fat Measurement

    12 months

  • FBG

    12 months

  • +28 more secondary outcomes

Study Arms (5)

MHO group

Metabolic healthy obesity

Procedure: Laparoscopic sleeve gastrectomy

HMO-U group

Hypermetabolic obesity-hyperuricemia

Procedure: Laparoscopic sleeve gastrectomy

HMO-I group

Hypermetabolic obesity-hyperinsulinemia

Procedure: Laparoscopic sleeve gastrectomy

LMO group

Hypometabolic obesity

Procedure: Laparoscopic sleeve gastrectomy

control group

Healthy person

Interventions

Laparoscopic sleeve gastrectomyPROCEDURE

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

HMO-I groupHMO-U groupLMO groupMHO group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

120 Patients from Shanghai Tenth People's Hospital were enrolled in this study.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shen Qu, Dr.

    Shanghai 10th People's Hospital

    STUDY CHAIR

Central Study Contacts

Shen Qu, Dr.

CONTACT

(86)021-66301004qushencn@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor and Principal Investigator

Study Record Dates

First Submitted

March 10, 2023

First Posted

June 7, 2023

Study Start

January 1, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

June 7, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)