Clinical Classification and Imaging Markers in Patients of Obesity

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Obesity; fMRI; Clinical Classification
• Intervention / Treatment: Other: Naturalistic observation

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Department of Endocrinology, Endocrine and Metabolic Disease Medical Center, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

This study is a dynamic prospective cohort study.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain imaging features in patients with obesity by fMRI	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.	From 2024 to 2028
Biomarkers of patients with obesity by blood sample	Diagnostic biomarkers, predictive biomarkers, and prognostic biomarker in patients with obesity by blood sample	From 2024 to 2028
Clinical classification of patients with obesity	Based on the exploration of the unique brain imaging and biomarkers in patients with obesity, the clinical classification of obese patients was carried out.	From 2024 to 2028
Prevention and intervention strategies for obesity based on clinical classification	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.	From 2024 to 2028

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Investigators: Study Director: Yan Bi, M.D., Ph.D., Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

Study record dates

Study Major Dates

• Study Start (Estimated): October 20, 2024
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): October 30, 2028

Study Registration Dates

• First Submitted: October 17, 2024
• First Submitted That Met QC Criteria: October 17, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: OB2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No