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Active, not recruitingNCT03975478BASALTOUpdated May 24, 2023

Bariatric Surgery and LDL Cholesterol

An interventional study of Gastric bypass and Sleeve gastrectomy in Bariatric Surgery, sponsored by Parc de Salut Mar. Active, not recruiting at 1 site in Spain. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-05-24.

Sponsored by Parc de Salut Mar · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

Read the detailed description

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 Cholesterol-lowering drugs will be withdrawn immediately after the surgical intervention to asses LDL cholesterol remission during follow-up.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.

02

Conditions studied

  • Bariatric Surgery

Keywords

  • bariatric surgery
  • gastric bypass
  • sleeve gastrectomy
  • LDL cholesterol
  • morbid obesity
03

In context

Lead sponsor

Parc de Salut Mar is the lead sponsor of 180 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Body mass index (BMI) ≥40 or BMI ≥35 kg/m2 with a significant obesity related comorbidities.
  • Age 18 - 60 years.
  • Previous successfully instituted and supervised but failed adequate diet and exercise program.
  • Elevated LDL cholesterol defined as LDL cholesterol concentration >130 mg/dL or treatment with cholesterol-lowering drugs.

Exclusion Criteria:

  • BMI >60 kg/m2.
  • Previous BS.

  • Exclusion criteria for BS:

    • Significant psychiatric disorder.
    • Severe eating disorder, active alcohol or substance abuse.
    • Contraindications for major abdominal surgery.
    • Active gastric ulcer disease.
    • Severe hepatic diseases.
    • Pregnancy or breastfeeding.

  • Cases in whom SG or GB are preferred:

    • Severe symptomatic gastro esophageal reflux disease despite medication.
    • Large hiatal hernia.
    • Expected dense adhesions at the level of the small bowel.
    • Need for endoscopic follow-up of the duodenum, history of inflammatory bowel disease.
    • History of renal transplantation in which drug malabsorption can be caused with a GB.

  • 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:

    • Established cardiovascular disease or subclinical cardiovascular disease (atheroma plaque detection in carotid ultrasonography exam) in which LDL cholesterol objectives are more aggressive or statins can be prescribed independently of LDL cholesterol levels.
    • LDL cholesterol >190 mg/dL or history of familial hypercholesterolemia.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
36 participants (estimated)

Study arms

  • Active comparator
    Gastric bypass

    Bariatric surgery by gastric bypass (GB)

    Procedure: Gastric bypass

  • Experimental
    Sleeve gastrectomy

    Bariatric surgery by sleeve gastrectomy (SG)

    Procedure: Sleeve gastrectomy

Interventions

  • ProcedureGastric bypass

    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.

  • ProcedureSleeve gastrectomy

    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.

06

What researchers measure

Primary outcomes

  1. LDL cholesterol remission 1 year after GB and SG

    Postoperative LDL cholesterol \<130 mg/dL without cholesterol-lowering drugs

    Time frame: At 12 months after surgery

Secondary outcomes

  1. LDL cholesterol remission at 3 months after GB and SG

    Postoperative LDL cholesterol \<130 mg/dL without cholesterol-lowering drugs

    Time frame: At 3 months after surgery

  2. LDL cholesterol remission at 6 months after GB and SG

    Postoperative LDL cholesterol \<130 mg/dL without cholesterol-lowering drugs

    Time frame: At 6 months after surgery

  3. 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.

    Time frame: At 12 months after surgery

  4. Hypertriglyceridemia remission postoperatively

    Triglyceride concentration \<150 mg/dL without fibrates

    Time frame: 12 months after surgery

  5. Low HDL cholesterol remission postoperatively

    HDL cholesterol concentration \>50 mg/dL in women, or \>40 mg/dL in men

    Time frame: 12 months after surgery

  6. Changes in LDL cholesterol concentration postoperatively

    Variation of LDL cholesterol concentration (mg/dL) with respect to preoperative value

    Time frame: At 3 months after surgery

  7. Changes in LDL cholesterol concentration postoperatively

    Variation of LDL cholesterol concentration (mg/dL) with respect to preoperative value

    Time frame: At 6 months after surgery

  8. Changes in LDL cholesterol concentration postoperatively

    Variation of LDL cholesterol concentration (mg/dL) with respect to preoperative value

    Time frame: At 12 months after surgery

  9. Changes in total cholesterol during follow-up

    Variation of total cholesterol concentration (mg/dL) with respect to preoperative value

    Time frame: At 3 months after surgery

  10. Changes in total cholesterol during follow-up

    Variation of total cholesterol concentration (mg/dL) with respect to preoperative value

    Time frame: At 6 months after surgery

  11. Changes in total cholesterol during follow-up

    Variation of total cholesterol concentration (mg/dL) with respect to preoperative value

    Time frame: At 12 months after surgery

  12. Changes in HDL cholesterol during follow-up

    Variation of HDL cholesterol concentration (mg/dL) with respect to preoperative value

    Time frame: At 3 months after surgery

  13. Changes in HDL cholesterol during follow-up

    Variation of HDL cholesterol concentration (mg/dL) with respect to preoperative value

    Time frame: At 6 months after surgery

  14. Changes in HDL cholesterol during follow-up

    Variation of HDL cholesterol concentration (mg/dL) with respect to preoperative value

    Time frame: At 12 months after surgery

  15. Changes in triglycerides during follow-up

    Variation of triglycerides concentration (mg/dL) with respect to preoperative value

    Time frame: At 3 months after surgery

  16. Changes in triglycerides during follow-up

    Variation of triglycerides concentration (mg/dL) with respect to preoperative value

    Time frame: At 6 months after surgery

  17. Changes in triglycerides during follow-up

    Variation of triglycerides concentration (mg/dL) with respect to preoperative value

    Time frame: At 12 months after surgery

  18. Changes in lipoprotein(a) during follow-up

    Variation of lipoprotein(a) concentration (mg/dL) with respect to preoperative value

    Time frame: At 3 months after surgery

  19. Changes in lipoprotein(a) during follow-up

    Variation of lipoprotein(a) concentration (mg/dL) with respect to preoperative value

    Time frame: At 6 months after surgery

  20. Changes in lipoprotein(a) during follow-up

    Variation of lipoprotein(a) concentration (mg/dL) with respect to preoperative value

    Time frame: At 12 months after surgery

  21. Changes in lipoproteins particle size

    Variation of LDL cholesterol particle size (nm) with respect to preoperative value

    Time frame: At 3 months postoperatively

  22. Changes in lipoproteins composition

    Variation of LDL cholesterol particles concentration (nmol/L) with respect to preoperative value

    Time frame: At 3 months postoperatively

  23. Changes in lipoproteins particle size

    Variation of LDL cholesterol particle size (nm) with respect to preoperative value

    Time frame: At 6 months postoperatively

  24. Changes in lipoproteins composition

    Variation of LDL cholesterol particles concentration (nmol/L) with respect to preoperative value

    Time frame: At 6 months postoperatively

  25. Changes in lipoproteins particle size

    Variation of LDL cholesterol particle size (nm) with respect to preoperative value

    Time frame: At 12 months postoperatively

  26. Changes in lipoproteins composition

    Variation of LDL cholesterol particles concentration (nmol/L) with respect to preoperative value

    Time frame: At 12 months postoperatively

  27. Change in patients' estimated cardiovascular risk

    Variation of REGICOR score (10-year estimated cardiovascular risk, %) with respect to preoperative value

    Time frame: At 3 months postoperatively

  28. Change in patients' estimated cardiovascular risk

    Variation of REGICOR score (10-year estimated cardiovascular risk, %) with respect to preoperative value

    Time frame: At 6 months postoperatively

  29. Change in patients' estimated cardiovascular risk

    Variation of REGICOR score (10-year estimated cardiovascular risk, %) with respect to preoperative value

    Time frame: At 12 months postoperatively

  30. Type 2 diabetes complete remission

    Glycated hemoglobin \[HbA1c\] value \<6.0% and fasting glucose level \<100 mg/dL without diabetes medications

    Time frame: At 3 months postoperatively

  31. Type 2 diabetes complete remission

    Glycated hemoglobin \[HbA1c\] value \<6.0% and fasting glucose level \<100 mg/dL without diabetes medications

    Time frame: At 6 months postoperatively

  32. Type 2 diabetes complete remission

    Glycated hemoglobin \[HbA1c\] value \<6.0% and fasting glucose level \<100 mg/dL without diabetes medications

    Time frame: At 12 months postoperatively

  33. 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

    Time frame: At 3 months postoperatively

  34. 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

    Time frame: At 6 months postoperatively

  35. 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

    Time frame: At 12 months postoperatively

  36. 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

    Time frame: At 12 months postoperatively

07

Study locations

1 site
  • Hospital del Mar
    Barcelona, 08003, Spain
08

References and documents

Publications

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  • Pihlajamaki J, Gronlund S, Simonen M, Kakela P, Moilanen L, Paakkonen M, Pirinen E, Kolehmainen M, Karja V, Kainulainen S, Uusitupa M, Alhava E, Miettinen TA, Gylling H. Cholesterol absorption decreases after Roux-en-Y gastric bypass but not after gastric banding. Metabolism. 2010 Jun;59(6):866-72. doi: 10.1016/j.metabol.2009.10.004. Epub 2009 Dec 16. PubMed 20015521 ↗
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  • Asztalos BF, Swarbrick MM, Schaefer EJ, Dallal GE, Horvath KV, Ai M, Stanhope KL, Austrheim-Smith I, Wolfe BM, Ali M, Havel PJ. Effects of weight loss, induced by gastric bypass surgery, on HDL remodeling in obese women. J Lipid Res. 2010 Aug;51(8):2405-12. doi: 10.1194/jlr.P900015. PubMed 20631298 ↗
  • Knopp RH, Gitter H, Truitt T, Bays H, Manion CV, Lipka LJ, LeBeaut AP, Suresh R, Yang B, Veltri EP; Ezetimibe Study Group. Effects of ezetimibe, a new cholesterol absorption inhibitor, on plasma lipids in patients with primary hypercholesterolemia. Eur Heart J. 2003 Apr;24(8):729-41. doi: 10.1016/s0195-668x(02)00807-2. PubMed 12713767 ↗
  • Samczuk P, Ciborowski M, Kretowski A. Application of Metabolomics to Study Effects of Bariatric Surgery. J Diabetes Res. 2018 Mar 11;2018:6270875. doi: 10.1155/2018/6270875. eCollection 2018. PubMed 29713650 ↗
  • Ramos-Molina B, Castellano-Castillo D, Alcaide-Torres J, Pastor O, de Luna Diaz R, Salas-Salvado J, Lopez-Moreno J, Fernandez-Garcia JC, Macias-Gonzalez M, Cardona F, Tinahones FJ. Differential effects of restrictive and malabsorptive bariatric surgery procedures on the serum lipidome in obese subjects. J Clin Lipidol. 2018 Nov-Dec;12(6):1502-1512. doi: 10.1016/j.jacl.2018.07.006. Epub 2018 Jul 25. PubMed 30143432 ↗
  • Buchwald H, Rudser KD, Williams SE, Michalek VN, Vagasky J, Connett JE. Overall mortality, incremental life expectancy, and cause of death at 25 years in the program on the surgical control of the hyperlipidemias. Ann Surg. 2010 Jun;251(6):1034-40. doi: 10.1097/SLA.0b013e3181deb4d0. PubMed 20485136 ↗
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  • Hutter MM, Schirmer BD, Jones DB, Ko CY, Cohen ME, Merkow RP, Nguyen NT. First report from the American College of Surgeons Bariatric Surgery Center Network: laparoscopic sleeve gastrectomy has morbidity and effectiveness positioned between the band and the bypass. Ann Surg. 2011 Sep;254(3):410-20; discussion 420-2. doi: 10.1097/SLA.0b013e31822c9dac. PubMed 21865942 ↗
  • Climent E, Benaiges D, Flores-Le Roux JA, Ramon JM, Pedro-Botet J, Goday A. Changes in the lipid profile 5 years after bariatric surgery: laparoscopic Roux-en-Y gastric bypass versus laparoscopic sleeve gastrectomy. Surg Obes Relat Dis. 2018 Aug;14(8):1099-1105. doi: 10.1016/j.soard.2018.05.006. Epub 2018 May 19. PubMed 29941302 ↗
  • Benaiges D, Goday A, Ramon JM, Hernandez E, Pera M, Cano JF; Obemar Group. Laparoscopic sleeve gastrectomy and laparoscopic gastric bypass are equally effective for reduction of cardiovascular risk in severely obese patients at one year of follow-up. Surg Obes Relat Dis. 2011 Sep-Oct;7(5):575-80. doi: 10.1016/j.soard.2011.03.002. Epub 2011 Mar 17. PubMed 21546321 ↗
  • 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. PubMed 32912989 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03975478
Lead sponsor
Parc de Salut Mar
Responsible party
Sponsor
First posted
Jun 5, 2019
Start date
Jul 23, 2019
Primary completion
Feb 28, 2023
Completion
Jul 2023 (estimated)
Last update
May 24, 2023

Study contacts

David Benaiges Boix, Dr
principal investigator · Hospital del Mar (Barcelona, Spain)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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