An interventional study of Single Anastomosis Sleeve Ileal Bypass and Roux-en-Y Gastric Bypass in Obesity, Morbid, sponsored by Hospitales Universitarios Virgen del Rocío. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Hospitales Universitarios Virgen del Rocío · Not applicable, Interventional, and Treatment
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.
936 studies on the registry are indexed under Obesity, Morbid; 169 are open to participants now.
This study's planned enrollment of 68 is above the median of 60 across 599 interventional studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →Hospitales Universitarios Virgen del Rocío is the lead sponsor of 33 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Participants assigned to this arm will undergo Single Anastomosis Sleeve Ileal Bypass (SASI), consisting of sleeve gastrectomy with a single gastroileal anastomosis.
Procedure: Single Anastomosis Sleeve Ileal Bypass
Participants assigned to this arm will undergo Roux-en-Y Gastric Bypass (RYGB), consisting of gastric pouch creation with gastrojejunal and jejunojejunal anastomoses.
Procedure: Roux-en-Y Gastric Bypass
Bariatric surgical procedure consisting of sleeve gastrectomy with a single gastroileal anastomosis.
Bariatric surgical procedure consisting of gastric pouch creation with gastrojejunal and jejunojejunal anastomoses.
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 surgery
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 surgery
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 surgery
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 surgery
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 surgery
Eating Behavior Assessed by TFEQ-R18
Eating behavior will be assessed using the Three-Factor Eating Questionnaire-Revised 18-item version (TFEQ-R18).
Time frame: Baseline, 6 months, and 12 months after surgery
Change in Type 2 Diabetes Mellitus Status
Changes in type 2 diabetes mellitus will be assessed using glycated hemoglobin (HbA1c) levels and changes in the requirement for insulin or oral glucose-lowering medications.
Time frame: Baseline, 3 months, 6 months, and 12 months after surgery
Change in Hypertension Status
Changes in hypertension will be assessed based on blood pressure measurements and changes in antihypertensive medication requirements.
Time frame: Baseline, 3 months, 6 months, and 12 months after surgery
Change in Dyslipidemia Status
Changes in dyslipidemia will be assessed based on serum lipid profile, including cholesterol and triglyceride levels, and changes in lipid-lowering medication requirements.
Time frame: Baseline, 3 months, 6 months, and 12 months after surgery
Nutritional Deficiencies
Nutritional status will be assessed using serum levels of iron, calcium, vitamin D, and vitamin B12.
Time frame: Baseline, 3 months, 6 months, and 12 months after surgery
Postoperative Complications
Incidence of postoperative complications, including gastroesophageal reflux, anastomotic leak, stenosis, and severe hypoglycemic episodes, will be recorded during follow-up.
Time frame: From surgery through 12 months after surgery
Percentage of Excess Weight Loss
Weight loss will be assessed as the percentage of excess weight loss (%EWL) after bariatric surgery.
Time frame: 3 months, 6 months, and 12 months after surgery
Percentage of Total Weight Loss
Weight loss will be assessed as the percentage of total weight loss (%TWL) from baseline body weight.
Time frame: 3 months, 6 months, and 12 months after surgery
Mean Amplitude of Glycemic Excursions
Mean amplitude of glycemic excursions (MAGE) will be calculated from continuous glucose monitoring data as a measure of short-term intraday glycemic variability.
Time frame: Baseline, 6 months, and 12 months after surgery
Time in Range
Time in range (TIR) will be calculated from continuous glucose monitoring data as the percentage of time that glucose values are between 70 and 180 mg/dL.
Time frame: Baseline, 6 months, and 12 months after surgery
Mean Glucose Concentration
Mean glucose concentration will be calculated from continuous glucose monitoring data collected over 7 days at each study time point.
Time frame: Baseline, 6 months, and 12 months after surgery
Glucose Standard Deviation
Glucose standard deviation will be calculated from continuous glucose monitoring data collected over 7 days at each study time point as a measure of short-term intraday glycemic variability.
Time frame: Baseline, 6 months, and 12 months after surgery
Plan to share: No
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Hospitales Universitarios Virgen del Rocío