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Bariatric Surgery and LDL Cholesterol (BASALTO)

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ClinicalTrials.gov Identifier: NCT03975478
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Parc de Salut Mar

Brief 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.


Condition or disease Intervention/treatment Phase
Bariatric Surgery Procedure: Gastric bypass Procedure: Sleeve gastrectomy Not Applicable

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 standarized 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 Cholesterol-lowering drugs will be withdrawn immediately after the surgical intervention to asses LDL cholesterol remission during follow-up.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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The researcher responsible for statistical analysis will be blinded to group allocation until data analysis is complete.
Primary Purpose: Treatment
Official Title: BASALTO (Bariatric Surgery and LDL Cholesterol) Trial
Actual Study Start Date : July 23, 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022


Arm Intervention/treatment
Active Comparator: Gastric bypass
Bariatric surgery by gastric bypass (GB)
Procedure: Gastric 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.

Experimental: Sleeve gastrectomy
Bariatric surgery by sleeve gastrectomy (SG)
Procedure: Sleeve 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.




Primary Outcome Measures :
  1. LDL cholesterol remission 1 year after GB and SG [ Time Frame: At 12 months after surgery ]
    Postoperative LDL cholesterol <130 mg/dL without cholesterol-lowering drugs


Secondary Outcome Measures :
  1. LDL cholesterol remission at 3 months after GB and SG [ Time Frame: At 3 months after surgery ]
    Postoperative LDL cholesterol <130 mg/dL without cholesterol-lowering drugs

  2. LDL cholesterol remission at 6 months after GB and SG [ Time Frame: At 6 months after surgery ]
    Postoperative LDL cholesterol <130 mg/dL without cholesterol-lowering drugs

  3. LDL cholesterol improvement postoperatively [ Time Frame: At 12 months after surgery ]

    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.


  4. Hypertriglyceridemia remission postoperatively [ Time Frame: 12 months after surgery ]
    Triglyceride concentration <150 mg/dL without fibrates

  5. Low HDL cholesterol remission postoperatively [ Time Frame: 12 months after surgery ]
    HDL cholesterol concentration >50 mg/dL in women, or >40 mg/dL in men

  6. Changes in LDL cholesterol concentration postoperatively [ Time Frame: At 3 months after surgery ]
    Variation of LDL cholesterol concentration (mg/dL) with respect to preoperative value

  7. Changes in LDL cholesterol concentration postoperatively [ Time Frame: At 6 months after surgery ]
    Variation of LDL cholesterol concentration (mg/dL) with respect to preoperative value

  8. Changes in LDL cholesterol concentration postoperatively [ Time Frame: At 12 months after surgery ]
    Variation of LDL cholesterol concentration (mg/dL) with respect to preoperative value

  9. Changes in total cholesterol during follow-up [ Time Frame: At 3 months after surgery ]
    Variation of total cholesterol concentration (mg/dL) with respect to preoperative value

  10. Changes in total cholesterol during follow-up [ Time Frame: At 6 months after surgery ]
    Variation of total cholesterol concentration (mg/dL) with respect to preoperative value

  11. Changes in total cholesterol during follow-up [ Time Frame: At 12 months after surgery ]
    Variation of total cholesterol concentration (mg/dL) with respect to preoperative value

  12. Changes in HDL cholesterol during follow-up [ Time Frame: At 3 months after surgery ]
    Variation of HDL cholesterol concentration (mg/dL) with respect to preoperative value

  13. Changes in HDL cholesterol during follow-up [ Time Frame: At 6 months after surgery ]
    Variation of HDL cholesterol concentration (mg/dL) with respect to preoperative value

  14. Changes in HDL cholesterol during follow-up [ Time Frame: At 12 months after surgery ]
    Variation of HDL cholesterol concentration (mg/dL) with respect to preoperative value

  15. Changes in triglycerides during follow-up [ Time Frame: At 3 months after surgery ]
    Variation of triglycerides concentration (mg/dL) with respect to preoperative value

  16. Changes in triglycerides during follow-up [ Time Frame: At 6 months after surgery ]
    Variation of triglycerides concentration (mg/dL) with respect to preoperative value

  17. Changes in triglycerides during follow-up [ Time Frame: At 12 months after surgery ]
    Variation of triglycerides concentration (mg/dL) with respect to preoperative value

  18. Changes in lipoprotein(a) during follow-up [ Time Frame: At 3 months after surgery ]
    Variation of lipoprotein(a) concentration (mg/dL) with respect to preoperative value

  19. Changes in lipoprotein(a) during follow-up [ Time Frame: At 6 months after surgery ]
    Variation of lipoprotein(a) concentration (mg/dL) with respect to preoperative value

  20. Changes in lipoprotein(a) during follow-up [ Time Frame: At 12 months after surgery ]
    Variation of lipoprotein(a) concentration (mg/dL) with respect to preoperative value

  21. Changes in lipoproteins particle size [ Time Frame: At 3 months postoperatively ]
    Variation of LDL cholesterol particle size (nm) with respect to preoperative value

  22. Changes in lipoproteins composition [ Time Frame: At 3 months postoperatively ]
    Variation of LDL cholesterol particles concentration (nmol/L) with respect to preoperative value

  23. Changes in lipoproteins particle size [ Time Frame: At 6 months postoperatively ]
    Variation of LDL cholesterol particle size (nm) with respect to preoperative value

  24. Changes in lipoproteins composition [ Time Frame: At 6 months postoperatively ]
    Variation of LDL cholesterol particles concentration (nmol/L) with respect to preoperative value

  25. Changes in lipoproteins particle size [ Time Frame: At 12 months postoperatively ]
    Variation of LDL cholesterol particle size (nm) with respect to preoperative value

  26. Changes in lipoproteins composition [ Time Frame: At 12 months postoperatively ]
    Variation of LDL cholesterol particles concentration (nmol/L) with respect to preoperative value

  27. Change in patients' estimated cardiovascular risk [ Time Frame: At 3 months postoperatively ]
    Variation of REGICOR score (10-year estimated cardiovascular risk, %) with respect to preoperative value

  28. Change in patients' estimated cardiovascular risk [ Time Frame: At 6 months postoperatively ]
    Variation of REGICOR score (10-year estimated cardiovascular risk, %) with respect to preoperative value

  29. Change in patients' estimated cardiovascular risk [ Time Frame: At 12 months postoperatively ]
    Variation of REGICOR score (10-year estimated cardiovascular risk, %) with respect to preoperative value

  30. Type 2 diabetes complete remission [ Time Frame: At 3 months postoperatively ]
    Glycated hemoglobin [HbA1c] value <6.0% and fasting glucose level <100 mg/dL without diabetes medications

  31. Type 2 diabetes complete remission [ Time Frame: At 6 months postoperatively ]
    Glycated hemoglobin [HbA1c] value <6.0% and fasting glucose level <100 mg/dL without diabetes medications

  32. Type 2 diabetes complete remission [ Time Frame: At 12 months postoperatively ]
    Glycated hemoglobin [HbA1c] value <6.0% and fasting glucose level <100 mg/dL without diabetes medications

  33. Type of mechanisms involved in the different LDL cholesterol remission rates after GB and SG [ Time Frame: At 3 months postoperatively ]
    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

  34. Type of mechanisms involved in the different LDL cholesterol remission rates after GB and SG [ Time Frame: At 6 months postoperatively ]
    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

  35. Type of mechanisms involved in the different LDL cholesterol remission rates after GB and SG [ Time Frame: At 12 months postoperatively ]
    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

  36. Changes in intima media thickness [ Time Frame: At 12 months postoperatively ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975478


Contacts
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Contact: David Benaiges Boix, Dr +34932483902 DBenaiges@parcdesalutmar.cat

Locations
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Spain
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Contact: David Benaiges Boix, Dr    +34932483902    DBenaiges@parcdesalutmar.cat   
Principal Investigator: David Benaiges Boix, Dr         
Sub-Investigator: Albert Goday Arnó, Dr         
Sponsors and Collaborators
Parc de Salut Mar
Investigators
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Principal Investigator: David Benaiges Boix, Dr Hospital del Mar (Barcelona, Spain)

Publications:
Ciurana Misol R, Franzi Sisó A, García Cerdán MR, Ríos Rodríguez MA, Ramos Blanes R, Solanas Saura P, et al. Guies de pràctica clínica. Colesterol i risc coronari. General Catalunya Inst Català de la Salut. 2009;1-131. Available from: http://www.gencat.cat/ics/professionals/guies/docs/material_docent_colesterol.pdf

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Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT03975478     History of Changes
Other Study ID Numbers: 2019/8471/I
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Parc de Salut Mar:
bariatric surgery
gastric bypass
sleeve gastrectomy
LDL cholesterol
morbid obesity