Overweight and ObesityNCT06268262
Surgical-imaging Research on Obesity (SIRO)
An observational study of Overweight and Obesity, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial summary
The global obesity epidemic is well established, and is an important public health issue. The previous researches had applied the clues that obesity is a kind of systemic disease. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to Dec 2028
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Aged between 18 and 65, regardless of gender. Initially diagnosed as obesity (BMI>28) and plan to undergo bariatric surgery.
Who may be able to join
- Meeting the obesity criteria (BMI > 28); 2) Meeting the indications for bariatric surgery, planning to undergo surgery for the first time; 3) Age between 18-65 years old, no gender restrictions; 4) Right-handed, of Han ethnicity; 5) Informed consent to the study, willing to cooperate with the research, and able to sign an informed consent form.
- Healthy volunteers with a BMI between 18.5-23.9;
- Age between 18-65 years old, no gender restrictions;
- Right-handed, of Han ethnicity;
- Informed consent to the study, willing to cooperate with the research, and able to sign an informed consent form.
Who cannot join
- Secondary obesity caused by other organic diseases or medication (such as hormone use, etc.);
- Unable to undergo surgery as planned;
- Pregnant or breastfeeding;
- Low cognitive ability and incapable of cooperating with the study;
- Eating disorders;
- Alcohol or drug dependence;
Show all 14Show fewer
- Meeting the criteria for organic mental disorders, severe mental disorders (schizophrenia, etc.), or other serious mental illnesses requiring clinical intervention;
- Contraindications for MR scanning (pacemakers, cochlear implants, metal objects in the body, claustrophobia, weight exceeding the machine's load limit, etc.);
- History of neurological organic diseases (brain tumors, epilepsy, cerebrovascular accidents, severe head trauma, etc.);
- History of congenital heart disease (myocardial infarction, severe arrhythmias, heart failure, cardiomyopathy, rheumatic heart disease, congenital heart disease, etc.);
- Severe liver, kidney, lung, digestive dysfunction, endocrine, and blood system diseases;
- Active infections within the last two weeks (fever, upper respiratory infection, acute gastroenteritis, etc.);
- Use of drugs affecting the nervous system or psychotropic drugs within the last six months.
- The same criteria as points 3) to 13) above.
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, 1 recruiting
- Recruiting
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
Kai Liu, M.D/Ph.D, +86-15920157720, liu-k@hotmail.com
About this study
Official title: Surgical-imaging Combined Research on Obesity
The global obesity epidemic is well established, and is an important public health issue. The previous researches had applied the clues that obesity is a kind of systemic disease. The investigators hypothesized that a serious alteration of the body systems will occur after bariatric surgery, which may shed light on the mechanisms of obesity. Thus, the research aims to combine the imaging and surgery to investigate the alterations of the body that induced by obese and alterations after surgery.
Read the detailed description
In 2016, the prevalence of obesity has already reached 13% of obesity and about 40% overweight worldwide. There is no doubt that obesity is linked to a broad spectrum of diseases，such as cardiovascular diseases, fatty liver diseases, polycystic ovarian syndrome and even central nervous systems disorders. For instance, in a review, author indicated the insulin resistance of T2DM occurs primarily in the muscles of lean individuals before they become obese. The central nervous system, especially the hypothalamus, has always considered to be the regulation center of food intake and hormonal regulation of energy homeostasis. In turn, obesity may worsen the regularity function of nervous system in several pathway. Based on the previous findings, the investigators hypothesized that a serious alterations of the body systems will occur after bariatric surgery, which may shed light on the mechanisms of obesity. The investigators plan to integrate the MR imaging, biological and epidemiological data thoroughly to investigate the alterations of the body that induced by obese and also followup the alterations that after surgery.
- Conditions
- Overweight and Obesity
- Keywords
- Obesity, Overweight, MRI, Bariatric surgery, Fatty liver
- Medical subject headings
- Overweight, Obesity, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obesity | Non-intervention | |
| Healthy control | Non-intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging parameters of obesity
Brain cortical thickness in millimeter
Measured: baseline, 6th month
Imaging parameters of obesity
The volume of left ventricle in cubic millimeter
Measured: baseline, 6th month
Imaging parameters of obesity
Fat fraction of liver (dividing the in-phase fat attenuation signal by the out-phase fat attenuation signal)
Measured: baseline, 6th month
Secondary outcomes (4)
Neurotransmitter, inflammatory factors and hormones related to obesity in blood sample
The level of 5-HT，GABA, TNF-a and estradiol in ng/L
Measured: baseline, 6th month
Neurotransmitter, inflammatory factors and hormones relating to obesity in blood sample
The level of BDNF in ng/ml
Measured: baseline, 6th month
Neurotransmitter, inflammatory factors and hormones related to obesity in blood sample
cortisol in μg/L
Measured: baseline, 6th month
Genetic information from venous blood sample, biopsied liver tissue, biopsied fat tissue, and gastric tissue
Screen and analyzing the DNA and RNA related to obesity
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Mar 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268262
- Sponsor's protocol ID
- XYFY2023-KL045-01
- Status last verified
- Mar 2024
- First submitted
- 6 Feb 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tutor AW, Lavie CJ, Kachur S, Milani RV, Ventura HO. Updates on obesity and the obesity paradox in cardiovascular diseases. Prog Cardiovasc Dis. 2023 May-Jun;78:2-10. doi: 10.1016/j.pcad.2022.11.013. Epub 2022 Dec 5.
PubMed 36481212Malone JI, Hansen BC. Does obesity cause type 2 diabetes mellitus (T2DM)? Or is it the opposite? Pediatr Diabetes. 2019 Feb;20(1):5-9. doi: 10.1111/pedi.12787. Epub 2018 Nov 5.
PubMed 30311716Schwartz MW, Woods SC, Porte D Jr, Seeley RJ, Baskin DG. Central nervous system control of food intake. Nature. 2000 Apr 6;404(6778):661-71. doi: 10.1038/35007534.
PubMed 10766253Raji CA, Meysami S, Hashemi S, Garg S, Akbari N, Gouda A, Chodakiewitz YG, Nguyen TD, Niotis K, Merrill DA, Attariwala R. Visceral and Subcutaneous Abdominal Fat Predict Brain Volume Loss at Midlife in 10,001 Individuals. Aging Dis. 2024 Aug 1;15(4):1831-1842. doi: 10.14336/AD.2023.0820.
PubMed 37728587Gutierrez-Cuevas J, Santos A, Armendariz-Borunda J. Pathophysiological Molecular Mechanisms of Obesity: A Link between MAFLD and NASH with Cardiovascular Diseases. Int J Mol Sci. 2021 Oct 27;22(21):11629. doi: 10.3390/ijms222111629.
PubMed 34769060
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical-imaging Combined Research on Obesity
- ClinicalTrials.gov ID
- NCT06268262
- Acronym / sponsor ID
- XYFY2023-KL045-01
- Conditions
- Overweight and Obesity
- Keywords
- Obesity, Overweight, MRI, Bariatric surgery, Fatty liver
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 20 Feb 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 obesity epidemic is well established, and is an important public health issue. The previous researches had applied the clues that obesity is a kind of systemic disease. The investigators hypothesized that a serious alteration of the body systems will occur after bariatric surgery, which may shed light on the mechanisms of obesity. Thus, the research aims to combine the imaging and surgery to investigate the alterations of the body that induced by obese and alterations after surgery.
Detailed description
In 2016, the prevalence of obesity has already reached 13% of obesity and about 40% overweight worldwide. There is no doubt that obesity is linked to a broad spectrum of diseases，such as cardiovascular diseases, fatty liver diseases, polycystic ovarian syndrome and even central nervous systems disorders. For instance, in a review, author indicated the insulin resistance of T2DM occurs primarily in the muscles of lean individuals before they become obese. The central nervous system, especially the hypothalamus, has always considered to be the regulation center of food intake and hormonal regulation of energy homeostasis. In turn, obesity may worsen the regularity function of nervous system in several pathway. Based on the previous findings, the investigators hypothesized that a serious alterations of the body systems will occur after bariatric surgery, which may shed light on the mechanisms of obesity. The investigators plan to integrate the MR imaging, biological and epidemiological data thoroughly to investigate the alterations of the body that induced by obese and also followup the alterations that after surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obesity | – | –Non-intervention |
| Healthy control | – | –Non-intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Aged between 18 and 65, regardless of gender. Initially diagnosed as obesity (BMI>28) and plan to undergo bariatric surgery.
Key inclusion criteria (5 listed)
- Meeting the obesity criteria (BMI > 28); 2) Meeting the indications for bariatric surgery, planning to undergo surgery for the first time; 3) Age between 18-65 years old, no gender restrictions; 4) Right-handed, of Han ethnicity; 5) Informed consent to the study, willing to cooperate with the research, and able to sign an informed consent form.
- Healthy volunteers with a BMI between 18.5-23.9;
- Age between 18-65 years old, no gender restrictions;
- Right-handed, of Han ethnicity;
- Informed consent to the study, willing to cooperate with the research, and able to sign an informed consent form.
Key exclusion criteria (14 listed)
- Secondary obesity caused by other organic diseases or medication (such as hormone use, etc.);
- Unable to undergo surgery as planned;
- Pregnant or breastfeeding;
- Low cognitive ability and incapable of cooperating with the study;
- Eating disorders;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Imaging parameters of obesity
Time frame: baseline, 6th month
Brain cortical thickness in millimeter
Imaging parameters of obesity
Time frame: baseline, 6th month
The volume of left ventricle in cubic millimeter
Imaging parameters of obesity
Time frame: baseline, 6th month
Fat fraction of liver (dividing the in-phase fat attenuation signal by the out-phase fat attenuation signal)
4 secondary outcomes
Neurotransmitter, inflammatory factors and hormones related to obesity in blood sample
Time frame: baseline, 6th month
Neurotransmitter, inflammatory factors and hormones relating to obesity in blood sample
Time frame: baseline, 6th month
Neurotransmitter, inflammatory factors and hormones related to obesity in blood sample
Time frame: baseline, 6th month
Genetic information from venous blood sample, biopsied liver tissue, biopsied fat tissue, and gastric tissue
Time frame: baseline
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 15 Mar 2024.
- Background: PubMed 36481212Tutor AW, Lavie CJ, Kachur S, Milani RV, Ventura HO. Updates on obesity and the obesity paradox in cardiovascular diseases. Prog Cardiovasc Dis. 2023 May-Jun;78:2-10. doi: 10.1016/j.pcad.2022.11.013. Epub 2022 Dec 5.
- Background: PubMed 30311716Malone JI, Hansen BC. Does obesity cause type 2 diabetes mellitus (T2DM)? Or is it the opposite? Pediatr Diabetes. 2019 Feb;20(1):5-9. doi: 10.1111/pedi.12787. Epub 2018 Nov 5.
- Background: PubMed 10766253Schwartz MW, Woods SC, Porte D Jr, Seeley RJ, Baskin DG. Central nervous system control of food intake. Nature. 2000 Apr 6;404(6778):661-71. doi: 10.1038/35007534.
- Background: PubMed 37728587Raji CA, Meysami S, Hashemi S, Garg S, Akbari N, Gouda A, Chodakiewitz YG, Nguyen TD, Niotis K, Merrill DA, Attariwala R. Visceral and Subcutaneous Abdominal Fat Predict Brain Volume Loss at Midlife in 10,001 Individuals. Aging Dis. 2024 Aug 1;15(4):1831-1842. doi: 10.14336/AD.2023.0820.
- Background: PubMed 34769060Gutierrez-Cuevas J, Santos A, Armendariz-Borunda J. Pathophysiological Molecular Mechanisms of Obesity: A Link between MAFLD and NASH with Cardiovascular Diseases. Int J Mol Sci. 2021 Oct 27;22(21):11629. doi: 10.3390/ijms222111629.
- Individual participant dataSharing planned: Undecided
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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.
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 Overweight and Obesity, run by The Affiliated Hospital of Xuzhou Medical 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 5 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 15 Mar 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?
Contact Kai Liu, Prof. (+86-15920157720, liu-k@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging parameters of obesity (time frame: baseline, 6th month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06268262, which also lists 5 linked publications.
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 15 Mar 2024.