Glycemic Variability After SASI Versus Roux-en-Y Gastric Bypass
ConditionObesity, Morbid
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-74
SponsorHospitales Universitarios Virgen del Rocío
About this trial
The GLUBARI trial is a prospective, randomized, single-center clinical study comparing two bariatric surgical procedures in adults with morbid obesity: Single Anastomosis Sleeve Ileal Bypass (SASI) and Roux-en-Y Gastric Bypass (RYGB). The main objective is to compare glycemic variability between the two procedures using continuous glucose monitoring. Participants will undergo continuous glucose monitoring for 7 days before surgery and again at 6 and 12 months after surgery. Secondary outcomes include hypoglycemic events, weight loss, resolution of obesity-related comorbidities, postoperative complications, gastroesophageal reflux, nutritional deficiencies, and quality of life. A total of 68 participants will be randomized in a 1:1 ratio to SASI or RYGB and followed for 12 months after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older and younger than 75 years.
Morbid obesity with body mass index (BMI) between 35 and 55 kg/m².
Pre-anesthetic assessment classified as ASA I-III.
Signed informed consent.
Disqualifiers
Body mass index (BMI) >55 kg/m².
Previous major gastrointestinal surgery.
Diseases that alter interstitial fluid volume and may affect glucose measurement accuracy, including severe acute or chronic renal failure, heart failure, or liver failure.
Pathological gastroesophageal reflux disease with endoscopic involvement.
Trial design
Design model
Parallel
Treatments tested in this trial
Single Anastomosis Sleeve Ileal Bypass
Procedure/SurgeryBariatric surgical procedure consisting of sleeve gastrectomy with a single gastroileal anastomosis.
Roux-en-Y Gastric Bypass
Procedure/SurgeryBariatric surgical procedure consisting of gastric pouch creation with gastrojejunal and jejunojejunal anastomoses.
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: Single Anastomosis Sleeve Ileal BypassExperimental treatment 1 intervention
Group B: Roux-en-Y Gastric BypassActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Glycemic Variability Assessed by Glucose Coefficient of Variation
Glycemic variability will be assessed using the glucose coefficient of variation (CV), calculated from 7 days of continuous glucose monitoring as the standard deviation of glucose divided by mean glucose concentration × 100. CV will be assessed at baseline, 6 months, and 12 months after surgery and compared between the SASI and Roux-en-Y gastric bypass groups.
Time frame
Baseline, 6 months, and 12 months after surgerySecondary outcomes
1
Hypoglycemic Events Detected by Continuous Glucose Monitoring
Number and frequency of symptomatic and asymptomatic hypoglycemic events detected during 7 days of continuous glucose monitoring. Symptomatic events will also be recorded using the participant event diary.
Time frame
Baseline, 6 months, and 12 months after surgery2
Body Mass Index
Body mass index (BMI) will be calculated as body weight in kilograms divided by height in meters squared (kg/m²).
Time frame
Baseline, 3 months, 6 months and 12 months after surgery3
Patient-Reported Outcomes Assessed by BODY-Q
Patient-reported outcomes related to quality of life and body image will be assessed using the BODY-Q questionnaire.
Time frame
Baseline, 6 months, and 12 months after surgery4
Gastroesophageal Reflux Symptoms Assessed by GERD-Q
Gastroesophageal reflux symptoms will be assessed using the GERD-Q questionnaire.
Time frame
Baseline, 6 months, and 12 months after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov