Clinical Classification and Imaging Markers in Patients of Obesity

• Conditions: Obesity; fMRI; Clinical Classification

• Registration Number: NCT06649071
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-17
• Study First Submitted QC: 2024-10-17
• Last Update Submitted: 2024-10-17
• Study First Posted: 2024-10-18
• Last Update Posted: 2024-10-18
• Study Start: 2024-10-20
• Primary Completion: 2028-10-30
• Study Completion: 2028-10-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brain imaging features in patients with obesity by fMRI	From 2024 to 2028	total brain volume, grey matter volume, white matter volume,cerebrospinal fluid volume, and nuclear bulk volume by MRI-derived normalized measures. All patients underwent odor-induced task fMRI on a 3.0T MR scanner with 222 volumes for task fMRI and 230 volumes for resting-state fMRI.
Biomarkers of patients with obesity by blood sample	From 2024 to 2028	Diagnostic biomarkers, predictive biomarkers, and prognostic biomarker in patients with obesity by blood sample
Clinical classification of patients with obesity	From 2024 to 2028	Based on the exploration of the unique brain imaging and biomarkers in patients with obesity, the clinical classification of obese patients was carried out.
Prevention and intervention strategies for obesity based on clinical classification	From 2024 to 2028	According to the clinical classification of obesity investigated in our previous study, personalized prevention and treatment strategies are designed to effectively slow down or reverse the obesity disease.

Trial Locations

Locations (1)

Department of Endocrinology, Endocrine and Metabolic Disease Medical Center, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University; 🇨🇳 Nanjing, Jiangsu, China