Bariatric Surgery and LDL Cholesterol

Bariatric Surgery Clinical Trial

— BASALTO  

Official title:

BASALTO (Bariatric Surgery and LDL Cholesterol) Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03975478
• Other study ID #: 2019/8471/I
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 23, 2019
• Est. completion date: July 2023

Study information

• Verified date: May 2023
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 Cholesterol-lowering drugs will be withdrawn immediately after the surgical intervention to asses LDL cholesterol remission during follow-up.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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: July 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

References & Publications (29)

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Climent E, Benaiges D, Pedro-Botet J, Goday A, Sola I, Ramon JM, Flores-LE Roux JA, Checa MA. Laparoscopic Roux-en-Y gastric bypass vs. laparoscopic sleeve gastrectomy for morbid obesity: a systematic review and meta-analysis of lipid effects at one year postsurgery. Minerva Endocrinol. 2018 Mar;43(1):87-100. doi: 10.23736/S0391-1977.17.02627-X. Epub 2017 Feb 15. — View Citation

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL cholesterol remission 1 year after GB and SG	Postoperative LDL cholesterol <130 mg/dL without cholesterol-lowering drugs	At 12 months after surgery
Secondary	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
Secondary	LDL cholesterol remission at 6 months after GB and SG	Postoperative LDL cholesterol <130 mg/dL without cholesterol-lowering drugs	At 6 months after surgery
Secondary	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
Secondary	Hypertriglyceridemia remission postoperatively	Triglyceride concentration <150 mg/dL without fibrates	12 months after surgery
Secondary	Low HDL cholesterol remission postoperatively	HDL cholesterol concentration >50 mg/dL in women, or >40 mg/dL in men	12 months after surgery
Secondary	Changes in LDL cholesterol concentration postoperatively	Variation of LDL cholesterol concentration (mg/dL) with respect to preoperative value	At 3 months after surgery
Secondary	Changes in LDL cholesterol concentration postoperatively	Variation of LDL cholesterol concentration (mg/dL) with respect to preoperative value	At 6 months after surgery
Secondary	Changes in LDL cholesterol concentration postoperatively	Variation of LDL cholesterol concentration (mg/dL) with respect to preoperative value	At 12 months after surgery
Secondary	Changes in total cholesterol during follow-up	Variation of total cholesterol concentration (mg/dL) with respect to preoperative value	At 3 months after surgery
Secondary	Changes in total cholesterol during follow-up	Variation of total cholesterol concentration (mg/dL) with respect to preoperative value	At 6 months after surgery
Secondary	Changes in total cholesterol during follow-up	Variation of total cholesterol concentration (mg/dL) with respect to preoperative value	At 12 months after surgery
Secondary	Changes in HDL cholesterol during follow-up	Variation of HDL cholesterol concentration (mg/dL) with respect to preoperative value	At 3 months after surgery
Secondary	Changes in HDL cholesterol during follow-up	Variation of HDL cholesterol concentration (mg/dL) with respect to preoperative value	At 6 months after surgery
Secondary	Changes in HDL cholesterol during follow-up	Variation of HDL cholesterol concentration (mg/dL) with respect to preoperative value	At 12 months after surgery
Secondary	Changes in triglycerides during follow-up	Variation of triglycerides concentration (mg/dL) with respect to preoperative value	At 3 months after surgery
Secondary	Changes in triglycerides during follow-up	Variation of triglycerides concentration (mg/dL) with respect to preoperative value	At 6 months after surgery
Secondary	Changes in triglycerides during follow-up	Variation of triglycerides concentration (mg/dL) with respect to preoperative value	At 12 months after surgery
Secondary	Changes in lipoprotein(a) during follow-up	Variation of lipoprotein(a) concentration (mg/dL) with respect to preoperative value	At 3 months after surgery
Secondary	Changes in lipoprotein(a) during follow-up	Variation of lipoprotein(a) concentration (mg/dL) with respect to preoperative value	At 6 months after surgery
Secondary	Changes in lipoprotein(a) during follow-up	Variation of lipoprotein(a) concentration (mg/dL) with respect to preoperative value	At 12 months after surgery
Secondary	Changes in lipoproteins particle size	Variation of LDL cholesterol particle size (nm) with respect to preoperative value	At 3 months postoperatively
Secondary	Changes in lipoproteins composition	Variation of LDL cholesterol particles concentration (nmol/L) with respect to preoperative value	At 3 months postoperatively
Secondary	Changes in lipoproteins particle size	Variation of LDL cholesterol particle size (nm) with respect to preoperative value	At 6 months postoperatively
Secondary	Changes in lipoproteins composition	Variation of LDL cholesterol particles concentration (nmol/L) with respect to preoperative value	At 6 months postoperatively
Secondary	Changes in lipoproteins particle size	Variation of LDL cholesterol particle size (nm) with respect to preoperative value	At 12 months postoperatively
Secondary	Changes in lipoproteins composition	Variation of LDL cholesterol particles concentration (nmol/L) with respect to preoperative value	At 12 months postoperatively
Secondary	Change in patients' estimated cardiovascular risk	Variation of REGICOR score (10-year estimated cardiovascular risk, %) with respect to preoperative value	At 3 months postoperatively
Secondary	Change in patients' estimated cardiovascular risk	Variation of REGICOR score (10-year estimated cardiovascular risk, %) with respect to preoperative value	At 6 months postoperatively
Secondary	Change in patients' estimated cardiovascular risk	Variation of REGICOR score (10-year estimated cardiovascular risk, %) with respect to preoperative value	At 12 months postoperatively
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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