Obesity, MorbidGLUBARINCT07872397
Glycemic Variability After SASI Versus Roux-en-Y Gastric Bypass
A study testing Single Anastomosis Sleeve Ileal Bypass and Roux-en-Y Gastric Bypass in people with Obesity, Morbid, run by Hospitales Universitarios Virgen del Rocío at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- Single Anastomosis Sleeve Ileal Bypass and Roux-en-Y Gastric Bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSpain
- Study dates
- 14 Jul 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Alcohol addiction.
- Active malignancy.
- Refusal to sign informed consent.
- Inability to comply with study instructions.'
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Virgen del Rocío
Seville, Sevilla, 41013
Isaías Alarcón del Agua, MD, PhD, +34646357875, isaiasalarcon@gmail.com
Isaías Alarcón del Agua, MD, PhD
About this study
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
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.
- Conditions
- Obesity, Morbid
- Being tested
- Single Anastomosis Sleeve Ileal Bypass, Roux-en-Y Gastric Bypass
- Keywords
- Glycemic Variability, Bariatric Surgery, Continuous Glucose Monitoring, Single Anastomosis Sleeve Ileal Bypass, Gastric Bypass
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Anastomosis Sleeve Ileal BypassProcedure or surgery
Bariatric surgical procedure consisting of sleeve gastrectomy with a single gastroileal anastomosis.
Roux-en-Y Gastric BypassProcedure or surgery
Bariatric surgical procedure consisting of gastric pouch creation with gastrojejunal and jejunojejunal anastomoses.
| Study group | Role | What they receive |
|---|---|---|
| Single Anastomosis Sleeve Ileal Bypass | Experimental | Participants assigned to this arm will undergo Single Anastomosis Sleeve Ileal Bypass (SASI), consisting of sleeve gastrectomy with a single gastroileal anastomosis. Receives: Procedure: Single Anastomosis Sleeve Ileal Bypass |
| Roux-en-Y Gastric Bypass | Active comparator | Participants assigned to this arm will undergo Roux-en-Y Gastric Bypass (RYGB), consisting of gastric pouch creation with gastrojejunal and jejunojejunal anastomoses. Receives: Procedure: Roux-en-Y Gastric Bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Variability Assessed by Glucose Coefficient of Variation
Glycemic variability will be assessed using the glucose coefficient of variation (CV), calculated from 7 days of continuous glucose monitoring as the standard deviation of glucose divided by mean glucose concentration × 100. CV will be assessed at baseline, 6 months, and 12 months after surgery and compared between the SASI and Roux-en-Y gastric bypass groups.
Measured: Baseline, 6 months, and 12 months after surgery
Secondary outcomes (16)
Hypoglycemic Events Detected by Continuous Glucose Monitoring
Number and frequency of symptomatic and asymptomatic hypoglycemic events detected during 7 days of continuous glucose monitoring. Symptomatic events will also be recorded using the participant event diary.
Measured: Baseline, 6 months, and 12 months after surgery
Body Mass Index
Body mass index (BMI) will be calculated as body weight in kilograms divided by height in meters squared (kg/m²).
Measured: Baseline, 3 months, 6 months and 12 months after surgery
Patient-Reported Outcomes Assessed by BODY-Q
Patient-reported outcomes related to quality of life and body image will be assessed using the BODY-Q questionnaire.
Measured: Baseline, 6 months, and 12 months after surgery
Gastroesophageal Reflux Symptoms Assessed by GERD-Q
Gastroesophageal reflux symptoms will be assessed using the GERD-Q questionnaire.
Measured: Baseline, 6 months, and 12 months after surgery
Eating Behavior Assessed by TFEQ-R18
Eating behavior will be assessed using the Three-Factor Eating Questionnaire-Revised 18-item version (TFEQ-R18).
Measured: Baseline, 6 months, and 12 months after surgery
Change in Type 2 Diabetes Mellitus Status
Changes in type 2 diabetes mellitus will be assessed using glycated hemoglobin (HbA1c) levels and changes in the requirement for insulin or oral glucose-lowering medications.
Measured: Baseline, 3 months, 6 months, and 12 months after surgery
Change in Hypertension Status
Changes in hypertension will be assessed based on blood pressure measurements and changes in antihypertensive medication requirements.
Measured: Baseline, 3 months, 6 months, and 12 months after surgery
Change in Dyslipidemia Status
Changes in dyslipidemia will be assessed based on serum lipid profile, including cholesterol and triglyceride levels, and changes in lipid-lowering medication requirements.
Measured: Baseline, 3 months, 6 months, and 12 months after surgery
Nutritional Deficiencies
Nutritional status will be assessed using serum levels of iron, calcium, vitamin D, and vitamin B12.
Measured: Baseline, 3 months, 6 months, and 12 months after surgery
Postoperative Complications
Incidence of postoperative complications, including gastroesophageal reflux, anastomotic leak, stenosis, and severe hypoglycemic episodes, will be recorded during follow-up.
Measured: From surgery through 12 months after surgery
Percentage of Excess Weight Loss
Weight loss will be assessed as the percentage of excess weight loss (%EWL) after bariatric surgery.
Measured: 3 months, 6 months, and 12 months after surgery
Percentage of Total Weight Loss
Weight loss will be assessed as the percentage of total weight loss (%TWL) from baseline body weight.
Measured: 3 months, 6 months, and 12 months after surgery
Mean Amplitude of Glycemic Excursions
Mean amplitude of glycemic excursions (MAGE) will be calculated from continuous glucose monitoring data as a measure of short-term intraday glycemic variability.
Measured: Baseline, 6 months, and 12 months after surgery
Time in Range
Time in range (TIR) will be calculated from continuous glucose monitoring data as the percentage of time that glucose values are between 70 and 180 mg/dL.
Measured: Baseline, 6 months, and 12 months after surgery
Mean Glucose Concentration
Mean glucose concentration will be calculated from continuous glucose monitoring data collected over 7 days at each study time point.
Measured: Baseline, 6 months, and 12 months after surgery
Glucose Standard Deviation
Glucose standard deviation will be calculated from continuous glucose monitoring data collected over 7 days at each study time point as a measure of short-term intraday glycemic variability.
Measured: Baseline, 6 months, and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start14 Jul 2026
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospitales Universitarios Virgen del Rocío
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isaías Alarcón del Agua, MD, PhD, Principal investigator, Hospitales Universitarios Virgen del Rocío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872397
- Sponsor's protocol ID
- GLUBARI-2025-06
- Acronym
- GLUBARI
- Status last verified
- Sep 2026
- First submitted
- 7 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07872397
- Acronym / sponsor ID
- GLUBARI / GLUBARI-2025-06
- Conditions
- Obesity, Morbid
- Keywords
- Glycemic Variability, Bariatric Surgery, Continuous Glucose Monitoring, Single Anastomosis Sleeve Ileal Bypass, Gastric Bypass
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Hospitales Universitarios Virgen del RocíoUniversity, hospital or other
- Study start
- 14 Jul 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Anastomosis Sleeve Ileal Bypass | Experimental | Procedure: Single Anastomosis Sleeve Ileal BypassParticipants assigned to this arm will undergo Single Anastomosis Sleeve Ileal Bypass (SASI), consisting of sleeve gastrectomy with a single gastroileal anastomosis. |
| Roux-en-Y Gastric Bypass | Active comparator | Procedure: Roux-en-Y Gastric BypassParticipants assigned to this arm will undergo Roux-en-Y Gastric Bypass (RYGB), consisting of gastric pouch creation with gastrojejunal and jejunojejunal anastomoses. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Anastomosis Sleeve Ileal BypassBariatric surgical procedure consisting of sleeve gastrectomy with a single gastroileal anastomosis. | Procedure or surgery | Single Anastomosis Sleeve Ileal Bypass |
| Roux-en-Y Gastric BypassBariatric surgical procedure consisting of gastric pouch creation with gastrojejunal and jejunojejunal anastomoses. | Procedure or surgery | Roux-en-Y Gastric Bypass |
Primary outcome
Glycemic Variability Assessed by Glucose Coefficient of Variation
Time frame: Baseline, 6 months, and 12 months after surgery
Glycemic variability will be assessed using the glucose coefficient of variation (CV), calculated from 7 days of continuous glucose monitoring as the standard deviation of glucose divided by mean glucose concentration × 100. CV will be assessed at baseline, 6 months, and 12 months after surgery and compared between the SASI and Roux-en-Y gastric bypass groups.
16 secondary outcomes
Hypoglycemic Events Detected by Continuous Glucose Monitoring
Time frame: Baseline, 6 months, and 12 months after surgery
Body Mass Index
Time frame: Baseline, 3 months, 6 months and 12 months after surgery
Patient-Reported Outcomes Assessed by BODY-Q
Time frame: Baseline, 6 months, and 12 months after surgery
Gastroesophageal Reflux Symptoms Assessed by GERD-Q
Time frame: Baseline, 6 months, and 12 months after surgery
Eating Behavior Assessed by TFEQ-R18
Time frame: Baseline, 6 months, and 12 months after surgery
Change in Type 2 Diabetes Mellitus Status
Time frame: Baseline, 3 months, 6 months, and 12 months after surgery
Change in Hypertension Status
Time frame: Baseline, 3 months, 6 months, and 12 months after surgery
Change in Dyslipidemia Status
Time frame: Baseline, 3 months, 6 months, and 12 months after surgery
Nutritional Deficiencies
Time frame: Baseline, 3 months, 6 months, and 12 months after surgery
Postoperative Complications
Time frame: From surgery through 12 months after surgery
Percentage of Excess Weight Loss
Time frame: 3 months, 6 months, and 12 months after surgery
Percentage of Total Weight Loss
Time frame: 3 months, 6 months, and 12 months after surgery
Mean Amplitude of Glycemic Excursions
Time frame: Baseline, 6 months, and 12 months after surgery
Time in Range
Time frame: Baseline, 6 months, and 12 months after surgery
Mean Glucose Concentration
Time frame: Baseline, 6 months, and 12 months after surgery
Glucose Standard Deviation
Time frame: Baseline, 6 months, and 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isaías Alarcón del Agua, MD, PhD principal investigator
Hospitales Universitarios Virgen del Rocío
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Anastomosis Sleeve Ileal Bypass and Roux-en-Y Gastric Bypass in people with Obesity, Morbid, run by Hospitales Universitarios Virgen del Rocío at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isaías Alarcón del Agua, MD, PhD (+ 34646357875, isaiasalarcon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Variability Assessed by Glucose Coefficient of Variation (time frame: Baseline, 6 months, and 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.