Duodenal-jejunal Bypass Sleeve (DJBS) for Obesity and Metabolic Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChinese University of Hong Kong
About this trial
This study is designed to evaluate the efficacy, safety, and mechanisms of duodenal-jejunal bypass sleeve in patients with obesity
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Body mass index (BMI) ≥27.5kg/m2; or BMI ≥25 kg/m2 with metabolic syndrome
Disqualifiers
Patients who have lost more than 5 kg of weight in the past three months
Patients who have used glucagon-like peptide-1 receptor agonists (GLP-1RAs) in the past three months
Patients who are currently taking weight loss drugs such as orlistat
Those who have taken antiplatelet drugs or anticoagulant drugs such as aspirin in the past month
Trial design
Design model
Single group
Treatments tested in this trial
Implantation of duodenal-jejunal bypass sleeve
Procedure/SurgeryThe duodenal-jejunal bypass sleeve (DJBS) is a 60 cm thin, flexible tube. It is implanted into the duodenum using an endoscopy procedure and is kept in place for 3 months. After 3 months, it will be removed endoscopically.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Duodenal-jejunal bypass sleeve (DJBS)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Excess body weight loss (%EBWL)
Percent excess body weight loss (%EBWL) from baseline to Month 12
Time frame
12 months post-procedureSecondary outcomes
1
Incidence of adverse events
Adverse events relating to endoscopic intervention, graded according to the Common Terminology Criteria for Adverse Events (CTCAE)
Time frame
within 30 days post-procedure2
Body fat percentage
Changes in body fat percentage - measured by bioelectrical impedance analysis from baseline to Month 12
Time frame
12 months post-procedure3
Duodenal and faecal microbiome
changes in duodenal and faecal microbiome from baseline to Month 24
Time frame
12 months post-procedure4
Improvement of liver steatosis
Changes in CAP (S0:best - S3:worst) on Fibroscan
Time frame
12 months post-procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Chinese University of Hong Kong
Lead sponsor
CUHK Medical Centre
Collaborator
Source ClinicalTrials.gov