NCT07872397 Glycemic Variability After SASI Versus Roux-en-Y Gastric Bypass
| NCT ID | NCT07872397 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospitales Universitarios Virgen del Rocío |
| Condition | Obesity, Morbid |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2026-07-14 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 68 participants in total. It began in 2026-07-14 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.'
Contact & Investigator
Isaías Alarcón del Agua, MD, PhD
PRINCIPAL INVESTIGATOR
Hospitales Universitarios Virgen del Rocío
Frequently Asked Questions
Who can join the NCT07872397 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 74 Years, studying Obesity, Morbid. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07872397 currently recruiting?
Yes, NCT07872397 is actively recruiting participants. Contact the research team at isaiasalarcon@gmail.com for enrollment information.
Where is the NCT07872397 trial being conducted?
This trial is being conducted at Seville, Spain.
Who is sponsoring the NCT07872397 clinical trial?
NCT07872397 is sponsored by Hospitales Universitarios Virgen del Rocío. The principal investigator is Isaías Alarcón del Agua, MD, PhD at Hospitales Universitarios Virgen del Rocío. The trial plans to enroll 68 participants.
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