Surgical-imaging Research on Obesity (SIRO)
ConditionOverweight and Obesity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorThe Affiliated Hospital of Xuzhou Medical University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial population
Aged between 18 and 65, regardless of gender. Initially diagnosed as obesity (BMI\>28) and plan to undergo bariatric surgery.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 2 trial groupsGroup A: Obesity
Group B: Healthy control
Trial outcomes
Primary outcomes
1
Imaging parameters of obesity
Brain cortical thickness in millimeter
Time frame
baseline, 6th month2
Imaging parameters of obesity
The volume of left ventricle in cubic millimeter
Time frame
baseline, 6th month3
Imaging parameters of obesity
Fat fraction of liver (dividing the in-phase fat attenuation signal by the out-phase fat attenuation signal)
Time frame
baseline, 6th monthSecondary outcomes
1
Neurotransmitter, inflammatory factors and hormones related to obesity in blood sample
The level of 5-HT，GABA, TNF-a and estradiol in ng/L
Time frame
baseline, 6th month2
Neurotransmitter, inflammatory factors and hormones relating to obesity in blood sample
The level of BDNF in ng/ml
Time frame
baseline, 6th month3
Neurotransmitter, inflammatory factors and hormones related to obesity in blood sample
cortisol in μg/L
Time frame
baseline, 6th month4
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
Time frame
baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov