ObesityNCT06649071
Clinical Classification and Imaging Markers in Patients of Obesity
An observational study of Obesity and fMRI, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
This is an observational study to explore the etiology and clinical classification in patients with obesity and to achieve personalized treatment. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, fMRI, Clinical Classification
- What is being tested?
- Naturalistic observation
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2024to 30 Oct 2028
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study is a dynamic prospective cohort study.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Endocrinology, Endocrine and Metabolic Disease Medical Center, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, 210008
About this study
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.
- Conditions
- Obesity, fMRI, Clinical Classification
- Being tested
- Naturalistic observation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naturalistic observationOther
Naturalistic observation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: From 2024 to 2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start20 Oct 2024 (estimated)
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Bi, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Yan Bi, M.D., Ph.D., Study director, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649071
- Sponsor's protocol ID
- OB2024
- Status last verified
- Oct 2024
- First submitted
- 17 Oct 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Classification and Imaging Markers in Patients of Obesity
- ClinicalTrials.gov ID
- NCT06649071
- Acronym / sponsor ID
- OB2024
- Conditions
- Obesity, fMRI, Clinical Classification
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 20 Oct 2024 (estimated)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study is a dynamic prospective cohort study.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naturalistic observationNaturalistic observation | Other | – |
Primary outcome
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.
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
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yan Bi, M.D., Ph.D. study director
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and fMRI, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain imaging features in patients with obesity by fMRI (time frame: From 2024 to 2028). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.