Glycemic variability after SASI versus Roux-en-Y gastric bypass
Official title: Comparison of Glycemic Variability After Bariatric Surgery With Single Anastomosis Sleeve Ileal Bypass (SASI) Versus Roux-en-Y Gastric Bypass (RYGB) Using Continuous Glucose Monitoring
Run by Hospitales Universitarios Virgen del Rocío · NCT07872397 · Data updated 2026-11-12
This trial tests whether SASI or Roux-en-Y gastric bypass leads to different glucose fluctuations in adults with severe obesity using continuous glucose monitoring.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 74 Years |
| Sex | All |
| Enrollment | 68 (estimated) |
| Sponsor | Hospitales Universitarios Virgen del Rocío Academic / other |
| Locations | 1 site (Seville, Sevilla) |
| Status | Recruiting |
| Started | July 14, 2026 |
| Main results expected | July 2028 |
| Study ends | July 2028 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT07872397 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to under 75 with morbid obesity (BMI 35–55 kg/m²) eligible for bariatric surgery.
✕Probably not a fit
Patients with BMI over 55, prior major GI surgery, severe organ failure, active cancer, or contraindications to surgery may not experience glycemic benefits from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, single-center trial comparing two bariatric procedures in adults with morbid obesity. Participants will wear continuous glucose monitors before surgery and at 6 and 12 months after surgery to measure glycemic variability. Secondary outcomes include hypoglycemic events, weight loss, resolution of obesity-related comorbidities, postoperative complications, reflux, nutritional deficiencies, and quality of life. A total of 68 participants will be randomly assigned 1:1 to SASI or Roux-en-Y gastric bypass and followed for 12 months. The study aims to clarify how these procedures impact glucose control and related health effects over the first year after surgery.
Why it matters
Potential benefit: If successful, the trial could help clinicians tailor bariatric surgery choices to improve glucose control in patients with obesity.
How similar studies have gone: Prior comparative studies of SASI and Roux-en-Y have shown differences in metabolic outcomes; this trial builds on that by focusing on glycemic variability via CGM in a randomized design.
Who can join: the full rules
Show full inclusion / exclusion 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.'
Where it's running
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Hospital Universitario Virgen del Rocío
Seville, Sevilla, Spain Recruiting
Study contacts
- Principal investigator: Isaías Alarcón del Agua, MD, PhD — Hospitales Universitarios Virgen del Rocío
- Study coordinator: Isaías Alarcón del Agua, MD, PhD
- Email: isaiasalarcon@gmail.com
- Phone: + 34646357875
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.