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Enrolling by Invitation

NCT Number: NCT06649071

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.

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Key information

Conditions

Obesity Body Weight Clinical Classification Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms fMRI

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Nanjing, Jiangsu, 210008, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Naturalistic observation

Other

Naturalistic observation

Primary outcomes

  1. Brain imaging features in patients with obesity by fMRI

    Time frame: 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.

  2. Biomarkers of patients with obesity by blood sample

    Time frame: From 2024 to 2028

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

  3. Clinical classification of patients with obesity

    Time frame: 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.

  4. Prevention and intervention strategies for obesity based on clinical classification

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 18, 2024
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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