Bariatric SurgeryBASALTONCT03975478
Bariatric Surgery and LDL Cholesterol
A study testing Gastric bypass and Sleeve gastrectomy in people with Bariatric Surgery, run by Parc de Salut Mar at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bariatric Surgery
- What is being tested?
- Gastric bypass and Sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 23 Jul 2019to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- BMI >60 kg/m2.
- Previous BS.
- Significant psychiatric disorder.
- Severe eating disorder, active alcohol or substance abuse.
- Contraindications for major abdominal surgery.
- Active gastric ulcer disease.
Show all 17Show fewer
- 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- Cholesterol lowering drugs will be withdrawn immediately after the surgical intervention to asses LDL cholesterol remission during follow-up. Cases in whom perioperative statins withdrawn cannot be adequate will be excluded: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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BASALTO (Bariatric Surgery and LDL Cholesterol) Trial
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.
Read more
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.
- Conditions
- Bariatric Surgery
- Being tested
- Gastric bypass, Sleeve gastrectomy
- Keywords
- bariatric surgery, gastric bypass, sleeve gastrectomy, LDL cholesterol, morbid obesity
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric bypassProcedure or surgery
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 gastrectomyProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Gastric bypass | Active comparator | Bariatric surgery by gastric bypass (GB) Receives: Procedure: Gastric bypass |
| Sleeve gastrectomy | Experimental | Bariatric surgery by sleeve gastrectomy (SG) Receives: Procedure: Sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL cholesterol remission 1 year after GB and SG
Postoperative LDL cholesterol <130 mg/dL without cholesterol-lowering drugs
Measured: At 12 months after surgery
Secondary outcomes (36)
LDL cholesterol remission at 3 months after GB and SG
Postoperative LDL cholesterol <130 mg/dL without cholesterol-lowering drugs
Measured: At 3 months after surgery
LDL cholesterol remission at 6 months after GB and SG
Postoperative LDL cholesterol <130 mg/dL without cholesterol-lowering drugs
Measured: 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.
Measured: At 12 months after surgery
Hypertriglyceridemia remission postoperatively
Triglyceride concentration <150 mg/dL without fibrates
Measured: 12 months after surgery
Low HDL cholesterol remission postoperatively
HDL cholesterol concentration >50 mg/dL in women, or >40 mg/dL in men
Measured: 12 months after surgery
Changes in LDL cholesterol concentration postoperatively
Variation of LDL cholesterol concentration (mg/dL) with respect to preoperative value
Measured: At 3 months after surgery
Changes in LDL cholesterol concentration postoperatively
Variation of LDL cholesterol concentration (mg/dL) with respect to preoperative value
Measured: At 6 months after surgery
Changes in LDL cholesterol concentration postoperatively
Variation of LDL cholesterol concentration (mg/dL) with respect to preoperative value
Measured: At 12 months after surgery
Changes in total cholesterol during follow-up
Variation of total cholesterol concentration (mg/dL) with respect to preoperative value
Measured: At 3 months after surgery
Changes in total cholesterol during follow-up
Variation of total cholesterol concentration (mg/dL) with respect to preoperative value
Measured: At 6 months after surgery
Changes in total cholesterol during follow-up
Variation of total cholesterol concentration (mg/dL) with respect to preoperative value
Measured: At 12 months after surgery
Changes in HDL cholesterol during follow-up
Variation of HDL cholesterol concentration (mg/dL) with respect to preoperative value
Measured: At 3 months after surgery
Changes in HDL cholesterol during follow-up
Variation of HDL cholesterol concentration (mg/dL) with respect to preoperative value
Measured: At 6 months after surgery
Changes in HDL cholesterol during follow-up
Variation of HDL cholesterol concentration (mg/dL) with respect to preoperative value
Measured: At 12 months after surgery
Changes in triglycerides during follow-up
Variation of triglycerides concentration (mg/dL) with respect to preoperative value
Measured: At 3 months after surgery
Changes in triglycerides during follow-up
Variation of triglycerides concentration (mg/dL) with respect to preoperative value
Measured: At 6 months after surgery
Changes in triglycerides during follow-up
Variation of triglycerides concentration (mg/dL) with respect to preoperative value
Measured: At 12 months after surgery
Changes in lipoprotein(a) during follow-up
Variation of lipoprotein(a) concentration (mg/dL) with respect to preoperative value
Measured: At 3 months after surgery
Changes in lipoprotein(a) during follow-up
Variation of lipoprotein(a) concentration (mg/dL) with respect to preoperative value
Measured: At 6 months after surgery
Changes in lipoprotein(a) during follow-up
Variation of lipoprotein(a) concentration (mg/dL) with respect to preoperative value
Measured: At 12 months after surgery
Changes in lipoproteins particle size
Variation of LDL cholesterol particle size (nm) with respect to preoperative value
Measured: At 3 months postoperatively
Changes in lipoproteins composition
Variation of LDL cholesterol particles concentration (nmol/L) with respect to preoperative value
Measured: At 3 months postoperatively
Changes in lipoproteins particle size
Variation of LDL cholesterol particle size (nm) with respect to preoperative value
Measured: At 6 months postoperatively
Changes in lipoproteins composition
Variation of LDL cholesterol particles concentration (nmol/L) with respect to preoperative value
Measured: At 6 months postoperatively
Changes in lipoproteins particle size
Variation of LDL cholesterol particle size (nm) with respect to preoperative value
Measured: At 12 months postoperatively
Changes in lipoproteins composition
Variation of LDL cholesterol particles concentration (nmol/L) with respect to preoperative value
Measured: At 12 months postoperatively
Change in patients' estimated cardiovascular risk
Variation of REGICOR score (10-year estimated cardiovascular risk, %) with respect to preoperative value
Measured: At 3 months postoperatively
Change in patients' estimated cardiovascular risk
Variation of REGICOR score (10-year estimated cardiovascular risk, %) with respect to preoperative value
Measured: At 6 months postoperatively
Change in patients' estimated cardiovascular risk
Variation of REGICOR score (10-year estimated cardiovascular risk, %) with respect to preoperative value
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start23 Jul 2019
- Primary completion28 Feb 2023
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Benaiges Boix, Dr, Principal investigator, Hospital del Mar (Barcelona, Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975478
- Sponsor's protocol ID
- 2019/8471/I
- Acronym
- BASALTO
- Status last verified
- May 2023
- First submitted
- 4 Jun 2019
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29029897Allison DB, Fontaine KR, Manson JE, Stevens J, VanItallie TB. Annual deaths attributable to obesity in the United States. JAMA. 1999 Oct 27;282(16):1530-8. doi: 10.1001/jama.282.16.1530.
PubMed 10546692Must A, Spadano J, Coakley EH, Field AE, Colditz G, Dietz WH. The disease burden associated with overweight and obesity. JAMA. 1999 Oct 27;282(16):1523-9. doi: 10.1001/jama.282.16.1523.
PubMed 10546691Grundy SM. Obesity, metabolic syndrome, and cardiovascular disease. J Clin Endocrinol Metab. 2004 Jun;89(6):2595-600. doi: 10.1210/jc.2004-0372. No abstract available.
PubMed 15181029Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724.
PubMed 15479938Sjostrom L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, Carlsson B, Dahlgren S, Larsson B, Narbro K, Sjostrom CD, Sullivan M, Wedel H; Swedish Obese Subjects Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004 Dec 23;351(26):2683-93. doi: 10.1056/NEJMoa035622.
PubMed 15616203Salminen P, Helmio M, Ovaska J, Juuti A, Leivonen M, Peromaa-Haavisto P, Hurme S, Soinio M, Nuutila P, Victorzon M. Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss at 5 Years Among Patients With Morbid Obesity: The SLEEVEPASS Randomized Clinical Trial. JAMA. 2018 Jan 16;319(3):241-254. doi: 10.1001/jama.2017.20313.
PubMed 29340676Schauer PR, Kashyap SR, Wolski K, Brethauer SA, Kirwan JP, Pothier CE, Thomas S, Abood B, Nissen SE, Bhatt DL. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012 Apr 26;366(17):1567-76. doi: 10.1056/NEJMoa1200225. Epub 2012 Mar 26.
PubMed 22449319Peterli R, Wolnerhanssen BK, Peters T, Vetter D, Kroll D, Borbely Y, Schultes B, Beglinger C, Drewe J, Schiesser M, Nett P, Bueter M. Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss in Patients With Morbid Obesity: The SM-BOSS Randomized Clinical Trial. JAMA. 2018 Jan 16;319(3):255-265. doi: 10.1001/jama.2017.20897.
PubMed 29340679Angrisani L, Santonicola A, Iovino P, Vitiello A, Zundel N, Buchwald H, Scopinaro N. Bariatric Surgery and Endoluminal Procedures: IFSO Worldwide Survey 2014. Obes Surg. 2017 Sep;27(9):2279-2289. doi: 10.1007/s11695-017-2666-x.
PubMed 28405878Arterburn D, Gupta A. Comparing the Outcomes of Sleeve Gastrectomy and Roux-en-Y Gastric Bypass for Severe Obesity. JAMA. 2018 Jan 16;319(3):235-237. doi: 10.1001/jama.2017.20449. No abstract available.
PubMed 29340659Climent 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.
PubMed 28206728Casajoana A, Pujol J, Garcia A, Elvira J, Virgili N, de Oca FJ, Duran X, Fernandez-Veledo S, Vendrell J, Vilarrasa N. Predictive Value of Gut Peptides in T2D Remission: Randomized Controlled Trial Comparing Metabolic Gastric Bypass, Sleeve Gastrectomy and Greater Curvature Plication. Obes Surg. 2017 Sep;27(9):2235-2245. doi: 10.1007/s11695-017-2669-7.
PubMed 28451931Schiavon CA, Bersch-Ferreira AC, Santucci EV, Oliveira JD, Torreglosa CR, Bueno PT, Frayha JC, Santos RN, Damiani LP, Noujaim PM, Halpern H, Monteiro FLJ, Cohen RV, Uchoa CH, de Souza MG, Amodeo C, Bortolotto L, Ikeoka D, Drager LF, Cavalcanti AB, Berwanger O. Effects of Bariatric Surgery in Obese Patients With Hypertension: The GATEWAY Randomized Trial (Gastric Bypass to Treat Obese Patients With Steady Hypertension). Circulation. 2018 Mar 13;137(11):1132-1142. doi: 10.1161/CIRCULATIONAHA.117.032130. Epub 2017 Nov 13.
PubMed 29133606Pihlajamaki 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
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BASALTO (Bariatric Surgery and LDL Cholesterol) Trial
- ClinicalTrials.gov ID
- NCT03975478
- Acronym / sponsor ID
- BASALTO / 2019/8471/I
- Conditions
- Bariatric Surgery
- Keywords
- bariatric surgery, gastric bypass, sleeve gastrectomy, LDL cholesterol, morbid obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- Jul 2023 (estimated)
- First posted
- 5 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric bypass | Active comparator | Procedure: Gastric bypassBariatric surgery by gastric bypass (GB) |
| Sleeve gastrectomy | Experimental | Procedure: Sleeve gastrectomyBariatric surgery by sleeve gastrectomy (SG) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- BMI >60 kg/m2.
- Previous 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric bypassThe 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 or surgery | Gastric bypass |
| Sleeve gastrectomyThe 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. | Procedure or surgery | Sleeve gastrectomy |
Primary outcome
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
36 secondary outcomes
LDL cholesterol remission at 3 months after GB and SG
Time frame: At 3 months after surgery
LDL cholesterol remission at 6 months after GB and SG
Time frame: At 6 months after surgery
LDL cholesterol improvement postoperatively
Time frame: At 12 months after surgery
Hypertriglyceridemia remission postoperatively
Time frame: 12 months after surgery
Low HDL cholesterol remission postoperatively
Time frame: 12 months after surgery
Changes in LDL cholesterol concentration postoperatively
Time frame: At 3 months after surgery
Changes in LDL cholesterol concentration postoperatively
Time frame: At 6 months after surgery
Changes in LDL cholesterol concentration postoperatively
Time frame: At 12 months after surgery
Changes in total cholesterol during follow-up
Time frame: At 3 months after surgery
Changes in total cholesterol during follow-up
Time frame: At 6 months after surgery
Changes in total cholesterol during follow-up
Time frame: At 12 months after surgery
Changes in HDL cholesterol during follow-up
Time frame: At 3 months after surgery
Changes in HDL cholesterol during follow-up
Time frame: At 6 months after surgery
Changes in HDL cholesterol during follow-up
Time frame: At 12 months after surgery
Changes in triglycerides during follow-up
Time frame: At 3 months after surgery
Changes in triglycerides during follow-up
Time frame: At 6 months after surgery
Changes in triglycerides during follow-up
Time frame: At 12 months after surgery
Changes in lipoprotein(a) during follow-up
Time frame: At 3 months after surgery
Changes in lipoprotein(a) during follow-up
Time frame: At 6 months after surgery
Changes in lipoprotein(a) during follow-up
Time frame: At 12 months after surgery
Changes in lipoproteins particle size
Time frame: At 3 months postoperatively
Changes in lipoproteins composition
Time frame: At 3 months postoperatively
Changes in lipoproteins particle size
Time frame: At 6 months postoperatively
Changes in lipoproteins composition
Time frame: At 6 months postoperatively
Changes in lipoproteins particle size
Time frame: At 12 months postoperatively
Changes in lipoproteins composition
Time frame: At 12 months postoperatively
Change in patients' estimated cardiovascular risk
Time frame: At 3 months postoperatively
Change in patients' estimated cardiovascular risk
Time frame: At 6 months postoperatively
Change in patients' estimated cardiovascular risk
Time frame: At 12 months postoperatively
Type 2 diabetes complete remission
Time frame: At 3 months postoperatively
Type 2 diabetes complete remission
Time frame: At 6 months postoperatively
Type 2 diabetes complete remission
Time frame: At 12 months postoperatively
Type of mechanisms involved in the different LDL cholesterol remission rates after GB and SG
Time frame: At 3 months postoperatively
Type of mechanisms involved in the different LDL cholesterol remission rates after GB and SG
Time frame: At 6 months postoperatively
Type of mechanisms involved in the different LDL cholesterol remission rates after GB and SG
Time frame: At 12 months postoperatively
Changes in intima media thickness
Time frame: At 12 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Background: PubMed 29029897NCD 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.
- Background: PubMed 10546692Allison DB, Fontaine KR, Manson JE, Stevens J, VanItallie TB. Annual deaths attributable to obesity in the United States. JAMA. 1999 Oct 27;282(16):1530-8. doi: 10.1001/jama.282.16.1530.
- Background: PubMed 10546691Must A, Spadano J, Coakley EH, Field AE, Colditz G, Dietz WH. The disease burden associated with overweight and obesity. JAMA. 1999 Oct 27;282(16):1523-9. doi: 10.1001/jama.282.16.1523.
- Background: PubMed 15181029Grundy SM. Obesity, metabolic syndrome, and cardiovascular disease. J Clin Endocrinol Metab. 2004 Jun;89(6):2595-600. doi: 10.1210/jc.2004-0372. No abstract available.
- Background: PubMed 15479938Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724.
- Background: PubMed 15616203Sjostrom L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, Carlsson B, Dahlgren S, Larsson B, Narbro K, Sjostrom CD, Sullivan M, Wedel H; Swedish Obese Subjects Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004 Dec 23;351(26):2683-93. doi: 10.1056/NEJMoa035622.
- Background: PubMed 29340676Salminen P, Helmio M, Ovaska J, Juuti A, Leivonen M, Peromaa-Haavisto P, Hurme S, Soinio M, Nuutila P, Victorzon M. Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss at 5 Years Among Patients With Morbid Obesity: The SLEEVEPASS Randomized Clinical Trial. JAMA. 2018 Jan 16;319(3):241-254. doi: 10.1001/jama.2017.20313.
- Background: PubMed 22449319Schauer PR, Kashyap SR, Wolski K, Brethauer SA, Kirwan JP, Pothier CE, Thomas S, Abood B, Nissen SE, Bhatt DL. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012 Apr 26;366(17):1567-76. doi: 10.1056/NEJMoa1200225. Epub 2012 Mar 26.
- Background: PubMed 29340679Peterli R, Wolnerhanssen BK, Peters T, Vetter D, Kroll D, Borbely Y, Schultes B, Beglinger C, Drewe J, Schiesser M, Nett P, Bueter M. Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss in Patients With Morbid Obesity: The SM-BOSS Randomized Clinical Trial. JAMA. 2018 Jan 16;319(3):255-265. doi: 10.1001/jama.2017.20897.
- Background: PubMed 28405878Angrisani L, Santonicola A, Iovino P, Vitiello A, Zundel N, Buchwald H, Scopinaro N. Bariatric Surgery and Endoluminal Procedures: IFSO Worldwide Survey 2014. Obes Surg. 2017 Sep;27(9):2279-2289. doi: 10.1007/s11695-017-2666-x.
- Background: PubMed 29340659Arterburn D, Gupta A. Comparing the Outcomes of Sleeve Gastrectomy and Roux-en-Y Gastric Bypass for Severe Obesity. JAMA. 2018 Jan 16;319(3):235-237. doi: 10.1001/jama.2017.20449. No abstract available.
- Background: PubMed 28206728Climent 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Benaiges Boix, Dr principal investigator
Hospital del Mar (Barcelona, Spain)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric bypass and Sleeve gastrectomy in people with Bariatric Surgery, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL cholesterol remission 1 year after GB and SG (time frame: At 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03975478, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.