Clinical Classification and Imaging Markers in Patients of Obesity

NCT06649071 | Enrolling By Invitation

• 1 other identifier: OB2024
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity; fMRI; Clinical Classification

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

Naturalistic observation OTHER

Naturalistic observation

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study is a dynamic prospective cohort study.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210008, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA and mRNA

MeSH Terms

Conditions

Obesity

Interventions

Observational Studies as Topic

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Yan Bi, M.D., Ph.D.

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 18, 2024
• Study Start: October 20, 2024
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): October 30, 2028
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)