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BS-GLP
RecruitingPhase 1, PHASE2Bariatric Surgery Combined With GLP-1 Receptor Agonists Study
The Efficacy and Safety of Bariatric Surgery Combined With GLP-1 Receptor Agonists for Patients With Severe Obesity: A Prospective, Multicenter Cohort Study
Lead sponsor
Asset
Semaglutide
GLP-1 agonist
Listed sites
1
Recruiting sites
1
Enrollment
200
estimated
Study population
Bariatric Surgery, Obesity / overweight
Key I/E criterion
•BMI ≥35
Primary endpoint
•Body weight, % change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Primary metabolic surgery candidates: Patients undergoing initial laparoscopic sleeve gastrectomy (LSG)
2. obesity:BMI ≥35 kg/m²
3. Metabolic comorbidities: Diagnosis of metabolic syndrome or type 2 diabetes mellitus (T2DM) meeting standard criteria
4. Age range: 18-60 years (inclusive)
5. Informed consent: Willing participation with documented consent
Exclusion criteria
1. Recent GLP-1RA use: Treatment with GLP-1 receptor agonists within 6 months preoperatively
2. Prior bariatric surgery: History of any metabolic/bariatric surgical procedure
3. Postoperative complications: Requiring reoperation for severe complications (e.g., hemorrhage, anastomotic leak)
4. Non-indicated candidates: Patients not meeting standard bariatric surgery indications
5. Significant comorbidities:
Endpoints (29)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
11 endpointsthe Percentage of weight loss
Time frame:1 year
Body weight, % change
percent change from baseline, improvement
Height in meters
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
Weight in kilograms
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Body weight, absolute change (kg)
change from baseline, improvement
Waist circumference in centimeters
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Waist circumference, change
change from baseline, improvement
Hip circumference in centimeters
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
change from baseline, improvement
body fat percentage(BFP)
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Total fat mass
descriptive
Visceral fat area
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Visceral fat, change
change from baseline, improvement
Muscle mass in kilograms
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Lean mass
descriptive, improvement
Body fat percentage
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Total fat mass
descriptive, improvement
lean body mass (LBM)
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Lean mass
descriptive, improvement
lean body mass percentage (LBMP)
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Lean mass
descriptive
Glycemic / diabetes
4 endpointsFasting blood glucose
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Average blood glucose from continuous glucose monitoring
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
Postprandial 2-hour blood glucose
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Postprandial glucose
descriptive, improvement
HbA1c
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
HbA1c, change
change from baseline, improvement
LOINC 4548-4
MASH / liver
2 endpointsAlanine Aminotransferase(ALT)
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
ALT, change
change from baseline, improvement
LOINC 1742-6
Aspartate Aminotransferase(AST)
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
AST, change
change from baseline, improvement
LOINC 1920-8
Renal / kidney
4 endpointsSerum creatinine
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
Glomerular filtration rate
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
eGFR, change
change from baseline, improvement
Urinary microalbumin and other Urinalysis indexes
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
urine microalbumin-to-creatinine ratio (ACR)
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
uACR, change
ratio, improvement
LOINC 9318-7
Cardiometabolic biomarkers
5 endpointsBlood pressure
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive, improvement
Total cholesterol
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Total cholesterol, change
change from baseline, improvement
LOINC 2093-3
Low-Density Lipoprotein(LDL)
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
LDL-C, change
change from baseline, improvement
LOINC 13457-7
High-Density Lipoprotein(HDL)
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
HDL-C, change
change from baseline, improvement
LOINC 2085-9
Triglycerides
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Triglycerides, change
change from baseline, improvement
LOINC 2571-8
Other (unclassified)
3 endpointsGender
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
Ethnicity
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
uric acid(UA)
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
change from baseline, descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.