Clinical trial NCT06649071: Clinical Classification and Imaging Markers in Patients of Obesity
Official title: Clinical Classification and Imaging Markers in Patients of Obesity
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Obesity
fMRI
Clinical Classification
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2024-10-18
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study is a dynamic prospective cohort study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Brain imaging features in patients with obesity by fMRI
timeFrame: From 2024 to 2028
measure: Biomarkers of patients with obesity by blood sample
timeFrame: From 2024 to 2028
measure: Clinical classification of patients with obesity
timeFrame: From 2024 to 2028
measure: Prevention and intervention strategies for obesity based on clinical classification
timeFrame: From 2024 to 2028
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Endocrinology, Endocrine and Metabolic Disease Medical Center, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
state: Jiangsu
Study officials:
affiliation: Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
name: Yan Bi, M.D., Ph.D.
role: STUDY_DIRECTOR
References: