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

RecruitingNAAges 18 Years - 74 YearsAllHospitales Universitarios Virgen del Rocío
NCT07872397 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.'
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What it tests

  • Single Anastomosis Sleeve Ileal Bypass
  • Roux-en-Y Gastric Bypass
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Where

1 site
Hospital Universitario Virgen del Rocío
Seville, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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