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Background:
Observational studies have shown that gastric bypass is superior to sleeve gastrectomy in terms of LDL cholesterol improvement. If these results are confirmed in randomized controlled trials, pre-surgical LDL cholesterol status should be a point to consider in the surgical procedure election.
Objective:
The primary objective is to compare 1-year LDL cholesterol remission after gastric bypass and sleeve gastrectomy in morbid obese patients.
Methods:
Phase 3, uni-centric, randomized clinical trial, with intention-to-treat analysis to compare LDL cholesterol remission between gastric bypass and sleeve gastrectomy with a 12 months follow-up. The inclusion criteria will be patients aged between 18-60 years old with a body mass index ≥40 or ≥35 kg/m2 with a significant obesity related comorbidity and high LDL cholesterol levels. Patients will be evaluated preoperatively (2 months before surgery) and at 3, 6 and 12 months after bariatric surgery. Examinations will include routine blood chemistry, anthropometric measures, food intake recall, physical activity questionnaires,intima media thickness, fecal samples for microbiota examinations, fat tissue samples and serum samples for lipidomics and hormonal analyses.
In the preoperative period, patients will follow a standard nutritional intervention that includes 6 monthly group sessions focused on achieving changes in dietary habits and hence ease adaptation after surgery.
In addition, lipid-lowering treatment will be adjusted and standardized following the Institut Català de la Salut clinical practice guidelines. Cholesterol-lowering drugs will be withdrawn immediately after the surgical intervention to asses LDL cholesterol remission during follow-up.
After surgery, a standardized protocol will be followed for the two groups in relation to dietary recommendations and physical activity, as well as the initiation of lipid-lowering medication after the intervention, in order to avoid the bias that may arise due to an open study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastric bypass | Active Comparator | Bariatric surgery by gastric bypass (GB) |
|
| Sleeve gastrectomy | Experimental | Bariatric surgery by sleeve gastrectomy (SG) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastric bypass | Procedure | The GB technique consists of a 150-cm antecolic Roux limb with a 25-mm circular pouch-jejunostomy and exclusion of 50 cm of the proximal jejunum. |
|
| Measure | Description | Time Frame |
|---|---|---|
| LDL cholesterol remission 1 year after GB and SG | Postoperative LDL cholesterol <130 mg/dL without cholesterol-lowering drugs | At 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| LDL cholesterol remission at 3 months after GB and SG | Postoperative LDL cholesterol <130 mg/dL without cholesterol-lowering drugs | At 3 months after surgery |
| LDL cholesterol remission at 6 months after GB and SG |
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Inclusion Criteria:
Exclusion Criteria:
BMI >60 kg/m2.
Previous BS.
Exclusion criteria for BS:
Cases in whom SG or GB are preferred:
Cholesterol lowering drugs will be withdrawn immediately after the surgical intervention to asses LDL cholesterol remission during follow-up. Cases in whom perioperative statins withdrawn cannot be adequate will be excluded:
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| Name | Affiliation | Role |
|---|---|---|
| David Benaiges Boix, Dr | Hospital del Mar (Barcelona, Spain) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Mar | Barcelona | 08003 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29029897 | Background | NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in body-mass index, underweight, overweight, and obesity from 1975 to 2016: a pooled analysis of 2416 population-based measurement studies in 128.9 million children, adolescents, and adults. Lancet. 2017 Dec 16;390(10113):2627-2642. doi: 10.1016/S0140-6736(17)32129-3. Epub 2017 Oct 10. | |
| 10546692 |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D015390 | Gastric Bypass |
| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
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The researcher responsible for statistical analysis will be blinded to group allocation until data analysis is complete.
| Sleeve gastrectomy | Procedure | The SG technique consists of a longitudinal resection of the stomach from the angle of His to approximately 5 cm proximal to the pylorus, using a 35 French bougie inserted along the lesser curvature. |
|
Postoperative LDL cholesterol <130 mg/dL without cholesterol-lowering drugs
| At 6 months after surgery |
| LDL cholesterol improvement postoperatively | In patients without preoperative cholesterol lowering drugs: Decrease ≥20% in LDL cholesterol concentration (mg/dL) without cholesterol-lowering drugs. In patients with preoperative cholesterol lowering drugs: Medication withdrawn and LDL cholesterol >130 mg/dL, or decrease ≥20% in LDL cholesterol concentration without medication withdrawn. | At 12 months after surgery |
| Hypertriglyceridemia remission postoperatively | Triglyceride concentration <150 mg/dL without fibrates | 12 months after surgery |
| Low HDL cholesterol remission postoperatively | HDL cholesterol concentration >50 mg/dL in women, or >40 mg/dL in men | 12 months after surgery |
| Changes in LDL cholesterol concentration postoperatively | Variation of LDL cholesterol concentration (mg/dL) with respect to preoperative value | At 3 months after surgery |
| Changes in LDL cholesterol concentration postoperatively | Variation of LDL cholesterol concentration (mg/dL) with respect to preoperative value | At 6 months after surgery |
| Changes in LDL cholesterol concentration postoperatively | Variation of LDL cholesterol concentration (mg/dL) with respect to preoperative value | At 12 months after surgery |
| Changes in total cholesterol during follow-up | Variation of total cholesterol concentration (mg/dL) with respect to preoperative value | At 3 months after surgery |
| Changes in total cholesterol during follow-up | Variation of total cholesterol concentration (mg/dL) with respect to preoperative value | At 6 months after surgery |
| Changes in total cholesterol during follow-up | Variation of total cholesterol concentration (mg/dL) with respect to preoperative value | At 12 months after surgery |
| Changes in HDL cholesterol during follow-up | Variation of HDL cholesterol concentration (mg/dL) with respect to preoperative value | At 3 months after surgery |
| Changes in HDL cholesterol during follow-up | Variation of HDL cholesterol concentration (mg/dL) with respect to preoperative value | At 6 months after surgery |
| Changes in HDL cholesterol during follow-up | Variation of HDL cholesterol concentration (mg/dL) with respect to preoperative value | At 12 months after surgery |
| Changes in triglycerides during follow-up | Variation of triglycerides concentration (mg/dL) with respect to preoperative value | At 3 months after surgery |
| Changes in triglycerides during follow-up | Variation of triglycerides concentration (mg/dL) with respect to preoperative value | At 6 months after surgery |
| Changes in triglycerides during follow-up | Variation of triglycerides concentration (mg/dL) with respect to preoperative value | At 12 months after surgery |
| Changes in lipoprotein(a) during follow-up | Variation of lipoprotein(a) concentration (mg/dL) with respect to preoperative value | At 3 months after surgery |
| Changes in lipoprotein(a) during follow-up | Variation of lipoprotein(a) concentration (mg/dL) with respect to preoperative value | At 6 months after surgery |
| Changes in lipoprotein(a) during follow-up | Variation of lipoprotein(a) concentration (mg/dL) with respect to preoperative value | At 12 months after surgery |
| Changes in lipoproteins particle size | Variation of LDL cholesterol particle size (nm) with respect to preoperative value | At 3 months postoperatively |
| Changes in lipoproteins composition | Variation of LDL cholesterol particles concentration (nmol/L) with respect to preoperative value | At 3 months postoperatively |
| Changes in lipoproteins particle size | Variation of LDL cholesterol particle size (nm) with respect to preoperative value | At 6 months postoperatively |
| Changes in lipoproteins composition | Variation of LDL cholesterol particles concentration (nmol/L) with respect to preoperative value | At 6 months postoperatively |
| Changes in lipoproteins particle size | Variation of LDL cholesterol particle size (nm) with respect to preoperative value | At 12 months postoperatively |
| Changes in lipoproteins composition | Variation of LDL cholesterol particles concentration (nmol/L) with respect to preoperative value | At 12 months postoperatively |
| Change in patients' estimated cardiovascular risk | Variation of REGICOR score (10-year estimated cardiovascular risk, %) with respect to preoperative value | At 3 months postoperatively |
| Change in patients' estimated cardiovascular risk | Variation of REGICOR score (10-year estimated cardiovascular risk, %) with respect to preoperative value | At 6 months postoperatively |
| Change in patients' estimated cardiovascular risk | Variation of REGICOR score (10-year estimated cardiovascular risk, %) with respect to preoperative value | At 12 months postoperatively |
| Type 2 diabetes complete remission | Glycated hemoglobin [HbA1c] value <6.0% and fasting glucose level <100 mg/dL without diabetes medications | At 3 months postoperatively |
| Type 2 diabetes complete remission | Glycated hemoglobin [HbA1c] value <6.0% and fasting glucose level <100 mg/dL without diabetes medications | At 6 months postoperatively |
| Type 2 diabetes complete remission | Glycated hemoglobin [HbA1c] value <6.0% and fasting glucose level <100 mg/dL without diabetes medications | At 12 months postoperatively |
| Type of mechanisms involved in the different LDL cholesterol remission rates after GB and SG | Different eligible types: Weight loss, changes in targeted lipidomics, changes in lipoproteins particles size and composition, changes in dietary habits and physical activity, modifications in gut microbiota, gene and protein expression in adipose tissue, changes in gut hormones | At 3 months postoperatively |
| Type of mechanisms involved in the different LDL cholesterol remission rates after GB and SG | Different eligible types: Weight loss, changes in targeted lipidomics, changes in lipoproteins particles size and composition, changes in dietary habits and physical activity, modifications in gut microbiota, gene and protein expression in adipose tissue, changes in gut hormones | At 6 months postoperatively |
| Type of mechanisms involved in the different LDL cholesterol remission rates after GB and SG | Different eligible types: Weight loss, changes in targeted lipidomics, changes in lipoproteins particles size and composition, changes in dietary habits and physical activity, modifications in gut microbiota, gene and protein expression in adipose tissue, changes in gut hormones | At 12 months postoperatively |
| Changes in intima media thickness | Variation of mean intima-media thickness (IMT, in mm) measured ultrasonographically in the far wall of bilateral common carotid arteries with respect to preoperative value | At 12 months postoperatively |
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| 41622097 | Derived | Benaiges D, Lazaro I, Goday A, Sala-Vila A, Haro N, Flores-Le Roux JA, Fito M, Casajoana A, Climent E, Alechaga E, Nebot P, Castaner O, Pedro-Botet J, Pozo OJ. Targeted lipidomics reveals distinct mechanisms driving LDL cholesterol response to gastric bypass and sleeve gastrectomy: An exploratory study. Nutr Metab Cardiovasc Dis. 2026 May;36(5):104567. doi: 10.1016/j.numecd.2026.104567. Epub 2026 Jan 13. |
| 38879559 | Derived | Benaiges D, Goday A, Casajoana A, Flores-Le Roux JA, Fito M, Pozo OJ, Serra C, Pera M, Llaurado G, Climent E, Villatoro M, Lazaro I, Castaner O, Pedro-Botet J. Short-term effects of gastric bypass versus sleeve gastrectomy on high LDL cholesterol: The BASALTO randomized clinical trial. Cardiovasc Diabetol. 2024 Jun 15;23(1):205. doi: 10.1186/s12933-024-02296-x. |
| 32912989 | Derived | Benaiges D, Goday A, Flores-Le Roux JA, Fito M, Pozo O, Rodriguez-Morato J, Serra C, Pera M, Llaurado G, Climent E, Castaner O, Ramon JM, Pedro-Botet J. Bariatric surgery and LDL cholesterol (BASALTO) trial study protocol: randomised controlled study evaluating the effect of gastric bypass versus sleeve gastrectomy on high LDL cholesterol. BMJ Open. 2020 Sep 10;10(9):e037712. doi: 10.1136/bmjopen-2020-037712. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005763 |
| Gastroenterostomy |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D013505 | Digestive System Surgical Procedures |