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NCT07872397
Glycemic Variability After SASI Versus Roux-en-Y Gastric Bypass
Conditions: Obesity, Morbid
Sex: All
Ages: 18 Years – 74 Years
Healthy volunteers: No
Phase: NA
Enrollment: 68
Sponsor: Hospitales Universitarios Virgen del Rocío
Location: Hospital Universitario Virgen del Rocío Seville Sevilla
Summary
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
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.'
Source: ClinicalTrials.gov (NCT07872397). StuddyBuddy aggregates publicly available trial information.