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Glycemic Variability After SASI Versus Roux-en-Y Gastric Bypass

Sponsor: Hospitales Universitarios Virgen del Rocío • ClinicalTrials.gov ID: NCT07872397

Registry updated: 2026-10-13

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Description

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.

Interventions

Single Anastomosis Sleeve Ileal Bypass (Procedure)
Bariatric surgical procedure consisting of sleeve gastrectomy with a single gastroileal anastomosis.
Roux-en-Y Gastric Bypass (Procedure)
Bariatric surgical procedure consisting of gastric pouch creation with gastrojejunal and jejunojejunal anastomoses.

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Pre-anesthetic assessment not suitable for surgery or ASA IV. * Pregnancy. * Alcohol addiction. * Active malignancy. * Refusal to sign informed consent. * Inability to comply with study instructions.'

Conditions

Obesity, Morbid

Locations

Hospital Universitario Virgen del Rocío — Seville, Sevilla, Spain

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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