Metabolic DiseaseNCT06725589
Brain Network Connectivity of Patients With Metabolic Diseases
An observational study of Metabolic Disease, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
The global prevalence of metabolic diseases, including hypertension, type 2 T2DM mellitus (T2DM), gout and obesity, has risen over the past two decades. Brain controls human behavior and metabolism in organisms. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disease
- What is being tested?
- metabolic disease
- How many people
- 690 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who underwent brain PET-CT examination in Sun Yat-sen Memorial Hospital from January 2018 to June 2024 and met our inclusion and exclusion criteria were included in the analysis. About 690 patients were included.
Who may be able to join
- Patients who underwent brain PET-CT in Sun Yat-sen Memorial Hospital from January 2018 to June 2024
Who cannot join
- Brain lesions, including patients with brain atrophy, cerebral ischemia and trauma, epilepsy, brain tumors, brain trauma, and psychiatric disorders; Patients with missing medical history or brain imaging data; Patients with tumor.
Trial locations and contacts
1 site in 1 country.
About this study
The global prevalence of metabolic diseases, including hypertension, type 2 T2DM mellitus (T2DM), gout and obesity, has risen over the past two decades. Brain controls human behavior and metabolism in organisms. It will be very interesting to explore whether there are similarities or relations among different metabolic diseases and how brain might be involved in the progression of different metabolic diseases.
We analyzed the PET-CT images and clinical biological markers of 112 cases of hypertension, 56 cases of T2DM, 11 cases of obesity, 14 cases of gout, and 497 cases without the above diseases. Standardized uptake value ratios (SUVRs) were extracted from different brain regions according to AAL brain atlas using Spatial-Normalization-of-Brain-PET-Images. Partial correlation analysis was used to analyze the correlation of the SUVRs of different brain regions with clinical biological markers by controlling sex, age and BMI. Brain network metabolic connectivity was analyzed using Permutation_IHEP software and visualized using BrainNet Viewer.
- Conditions
- Metabolic Disease
- Being tested
- metabolic disease
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metabolic diseaseOther
metabolic disease
| Study group | Role | What they receive |
|---|---|---|
| hypertension, T2DM, obesity, gout, and patients without the above diseases | hypertension, T2DM, obesity, gout, and patients without the above diseases Receives: Other: metabolic disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
the correlation between metabolic changes in different brain regions and blood test results in patients without metabolic diseases, hypertension, T2DM, gout and obesity
Measured: 2024.01-2024.06
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Jan 2024
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseaseStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 690 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725589
- Sponsor's protocol ID
- SYSKY-2024-706-01
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Network Connectivity of Patients With Metabolic Diseases
- ClinicalTrials.gov ID
- NCT06725589
- Acronym / sponsor ID
- SYSKY-2024-706-01
- Conditions
- Metabolic Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 690 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 10 Dec 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.
The global prevalence of metabolic diseases, including hypertension, type 2 T2DM mellitus (T2DM), gout and obesity, has risen over the past two decades. Brain controls human behavior and metabolism in organisms. It will be very interesting to explore whether there are similarities or relations among different metabolic diseases and how brain might be involved in the progression of different metabolic diseases.
We analyzed the PET-CT images and clinical biological markers of 112 cases of hypertension, 56 cases of T2DM, 11 cases of obesity, 14 cases of gout, and 497 cases without the above diseases. Standardized uptake value ratios (SUVRs) were extracted from different brain regions according to AAL brain atlas using Spatial-Normalization-of-Brain-PET-Images. Partial correlation analysis was used to analyze the correlation of the SUVRs of different brain regions with clinical biological markers by controlling sex, age and BMI. Brain network metabolic connectivity was analyzed using Permutation_IHEP software and visualized using BrainNet Viewer.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hypertension, T2DM, obesity, gout, and patients without the above diseases | – | Other: metabolic diseasehypertension, T2DM, obesity, gout, and patients without the above diseases |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent brain PET-CT examination in Sun Yat-sen Memorial Hospital from January 2018 to June 2024 and met our inclusion and exclusion criteria were included in the analysis. About 690 patients were included.
Key inclusion criteria (1 listed)
- Patients who underwent brain PET-CT in Sun Yat-sen Memorial Hospital from January 2018 to June 2024
Key exclusion criteria (1 listed)
- Brain lesions, including patients with brain atrophy, cerebral ischemia and trauma, epilepsy, brain tumors, brain trauma, and psychiatric disorders; Patients with missing medical history or brain imaging data; Patients with tumor.
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 |
|---|---|---|
| metabolic diseasemetabolic disease | Other | hypertension, T2DM, obesity, gout, and patients without the above diseases |
Primary outcome
the correlation between metabolic changes in different brain regions and blood test results in patients without metabolic diseases, hypertension, T2DM, gout and obesity
Time frame: 2024.01-2024.06
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Metabolic Disease, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the correlation between metabolic changes in different brain regions and blood test results in patients without metabolic diseases, hypertension, T2DM, gout and obesity (time frame: 2024.01-2024.06). 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 10 Dec 2024.