Clinical Classification and Imaging Markers in Patients of Obesity

NCT ID: NCT06649071

Last Updated: 2024-10-18

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

ENROLLING_BY_INVITATION

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-20

Study Completion Date

2028-10-30

Brief Summary

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This is an observational study to explore the etiology and clinical classification in patients with obesity and to achieve personalized treatment.

Detailed Description

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In this project, individuals with obesity and control individuals were recruited and followed up every year. Clinical neuropsychological scores, olfactory function tests, and functional magnetic resonance imaging (fmri) were performed to describe the brain function characteristics under different odor stimulation in fasting and after eating, and to explore the pathogenesis and clinical classification of obese patients. The correlation analysis between imaging analysis values and clinical laboratory data, neuropsychological scores and olfactory behavior scores was performed to explore indicators related to cognitive decline and provide new insights into the etiology and classification of obese patients. Combined with clinical evaluation and imaging examination, the changes of cognitive behavior and brain structure and function in obese patients were followed up.

Conditions

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Obesity fMRI Clinical Classification

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Naturalistic observation

Naturalistic observation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with BMI≥28kg/m2
* Aged 18-65 years of both sexes, right-handed
* At least 6 years of education
* Patients agreed and signed the informed consent

Exclusion Criteria

* Fewer than 6 years of education
* Left-handedness
* Dementia
* Acute metabolic complications such as diabetic ketoacidosis
* Hyperglycaemic hyperosmolar state and hypoglycaemic coma within the previous 3 months; history or presence of neurological or psychiatric disorders;
* Presence of hypothyroidism;
* History of malignancy, or severe kidney or liver dysfunction.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role lead

Responsible Party

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Yan Bi

Clinical Professor, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yan Bi, M.D., Ph.D.

Role: STUDY_DIRECTOR

Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

Locations

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Department of Endocrinology, Endocrine and Metabolic Disease Medical Center, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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OB2024

Identifier Type: -

Identifier Source: org_study_id

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