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Bariatric Surgery and LDL Cholesterol (BASALTO)

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ClinicalTrials.gov Identifier: NCT03975478
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Parc de Salut Mar

Tracking Information
First Submitted Date  ICMJE June 4, 2019
First Posted Date  ICMJE June 5, 2019
Last Update Posted Date June 13, 2019
Estimated Study Start Date  ICMJE June 2019
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03975478 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
  • 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
  • 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
  • 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 In patients with preoperative cholesterol lowering drugs: Medication withdrawn and LDL cholesterol 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130 mg/dL, or decrease ≥20% in LDL cholesterol concentration without medication withdrawn.
  • Hypertriglyceridemia remission postoperatively [ Time Frame: 12 months after surgery ]
    Triglyceride concentration <150 mg/dL without fibrates
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Changes in triglycerides during follow-up [ Time Frame: At 3 months after surgery ]
    Variation of triglycerides concentration (mg/dL) with respect to preoperative value
  • Changes in triglycerides during follow-up [ Time Frame: At 6 months after surgery ]
    Variation of triglycerides concentration (mg/dL) with respect to preoperative value
  • Changes in triglycerides during follow-up [ Time Frame: At 12 months after surgery ]
    Variation of triglycerides concentration (mg/dL) with respect to preoperative value
  • 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
  • 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
  • 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
  • Changes in lipoproteins particle size [ Time Frame: At 3 months postoperatively ]
    Variation of LDL cholesterol particle size (nm) with respect to preoperative value
  • Changes in lipoproteins composition [ Time Frame: At 3 months postoperatively ]
    Variation of LDL cholesterol particles concentration (nmol/L) with respect to preoperative value
  • Changes in lipoproteins particle size [ Time Frame: At 6 months postoperatively ]
    Variation of LDL cholesterol particle size (nm) with respect to preoperative value
  • Changes in lipoproteins composition [ Time Frame: At 6 months postoperatively ]
    Variation of LDL cholesterol particles concentration (nmol/L) with respect to preoperative value
  • Changes in lipoproteins particle size [ Time Frame: At 12 months postoperatively ]
    Variation of LDL cholesterol particle size (nm) with respect to preoperative value
  • Changes in lipoproteins composition [ Time Frame: At 12 months postoperatively ]
    Variation of LDL cholesterol particles concentration (nmol/L) with respect to preoperative value
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bariatric Surgery and LDL Cholesterol
Official Title  ICMJE BASALTO (Bariatric Surgery and LDL Cholesterol) Trial
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Bariatric Surgery
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Gastric bypass
    Bariatric surgery by gastric bypass (GB)
    Intervention: Procedure: Gastric bypass
  • Experimental: Sleeve gastrectomy
    Bariatric surgery by sleeve gastrectomy (SG)
    Intervention: Procedure: Sleeve gastrectomy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 4, 2019)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David Benaiges Boix, Dr +34932483902 DBenaiges@parcdesalutmar.cat
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03975478
Other Study ID Numbers  ICMJE 2019/8471/I
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Parc de Salut Mar
Study Sponsor  ICMJE Parc de Salut Mar
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Benaiges Boix, Dr Hospital del Mar (Barcelona, Spain)
PRS Account Parc de Salut Mar
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP