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Enrolling by invitationNCT06649071Updated Oct 18, 2024

Clinical Classification and Imaging Markers in Patients of Obesity

An observational study in Obesity, fMRI and Clinical Classification, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Enrolling by invitation at 1 site in China. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-18.

Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
20 Years to 65 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Obesity
  • fMRI
  • Clinical Classification

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In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 100 is below the median of 135 across 1,283 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 242 studies on the registry; 144 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

This study is a dynamic prospective cohort study.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
4 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Interventions

  • OtherNaturalistic observation

    Naturalistic observation

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: From 2024 to 2028

  2. Biomarkers of patients with obesity by blood sample

    Diagnostic biomarkers, predictive biomarkers, and prognostic biomarker in patients with obesity by blood sample

    Time frame: From 2024 to 2028

  3. 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.

    Time frame: From 2024 to 2028

  4. 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.

    Time frame: From 2024 to 2028

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Study locations

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

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06649071
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Responsible party
Yan Bi (Clinical Professor, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School) — Principal investigator
First posted
Oct 18, 2024
Start date
Oct 20, 2024 (estimated)
Primary completion
Oct 30, 2028 (estimated)
Completion
Oct 30, 2028 (estimated)
Last update
Oct 18, 2024

Study contacts

Yan Bi, M.D., Ph.D.
study director · Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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