Laparoscopic Gastric Bypass Versus Sleeve Gastrectomy to Treat Morbid Obesity (SLEEVEPASS)
A Randomized Prospective Three-center Study: Laparoscopic Gastric Bypass vs. Laparoscopic Sleeve Gastrectomy in the Treatment of Morbid Obesity
Visão geral do estudo
Status
Condições
Descrição detalhada
In addition to comparing the outcomes between sleeve gastrectomy and gastric bypass, the study project includes a PET trial conducted in Turku. The objectives of this PET study are to measure effect of obesity on food-stimuli mediated brain activation response and on hormones affecting both feeding and energy balance. In the second part the same variables are studied after bariatric surgery: either laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass. In addition the effect of weight loss due to bariatric surgery on glucose uptake and free fatty acid metabolism is measured. The objective is also to study whether less invasive sleeve gastrectomy is as beneficial in terms of weight loss and co-morbid diseases as more invasive Roux-en-Y gastric bypass and to compare the risk factors between these two surgical procedures. Regional glucose uptake and free fatty acid uptake in myocardium, skeletal muscle, subcutaneous fat, visceral fat, pancreas, liver and brain are studied with PET at baseline before bariatric surgery and post-operatively on the 3rd month. Changes in body fat distribution, in ectopic fat and fat content of key organs are investigated with magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS). Brain reward system response to food stimuli is assessed using functional MRI (fMRI) and white and grey matter volumes using diffusion tensor imaging (DTI).
The study consists of 80 morbidly obese adults, BMI ≥ 40 kg/m2 or if there is additional risk factor BMI ≥ 35 kg/m2. From these subjects, 40 are further studied with positron emission tomography (PET) and magnetic resonance imaging (MRI). In addition functional MRI (fMRI) will be performed for 40 subjects. For fMRI, a control group is recruited consisting of 20 lean and healthy subjects. Subjects are physically examined and anthropometric data are measured along with blood sampling.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Helsinki, Finlândia
- Helsinki University Hospital
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Turku, Finlândia, 20520
- Department of Surgery, Turku University Central Hospital
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Turku, Finlândia
- Turku University Hospital, PET-center
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Vaasa, Finlândia
- Vaasa Central Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- BMI > 40 or BMI > 35 with a comorbidity associated with obesity
- Age 18 - 60 years
- Failed prior effective and controlled conservative treatments of morbid obesity
Exclusion Criteria:
- BMI > 60
- Difficult psychiatric conditions or lack of co-operation
- Difficult eating disorder (binge eating, bulimia etc.)
- Alcohol abuse
- Gastric ulcer
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Sleeve
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Bypass
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Excessive weight loss
Prazo: 3,6,12,18 months, 2,3,5,7,10,15 years
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3,6,12,18 months, 2,3,5,7,10,15 years
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Resolution of comorbidities
Prazo: 3,6,12,18 months, 2,3,5,7,10,15 years
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3,6,12,18 months, 2,3,5,7,10,15 years
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Mortality
Prazo: 0 - 15 years
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0 - 15 years
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Morbidity
Prazo: 0 - 15 years
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0 - 15 years
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QOL (15D and BAROS)
Prazo: 3,6,12,18 months, 2,3,5,7,10,15 years
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3,6,12,18 months, 2,3,5,7,10,15 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mikael Victorzon, MD, PhD, Vaasa Central Hospital, Vaasa, Finland
- Investigador principal: Paulina Salminen, MD, PhD, Turku Univeristy Central Hospital
- Investigador principal: Jari Ovaska, Md, PhD, University of Turku
Publicações e links úteis
Publicações Gerais
- Savolainen AM, Karmi A, Immonen H, Soinio M, Saunavaara V, Pham T, Salminen P, Helmio M, Ovaska J, Loyttyniemi E, Heiskanen MA, Lehtimaki T, Mari A, Nuutila P, Hannukainen JC. Physical Activity Associates with Muscle Insulin Sensitivity Postbariatric Surgery. Med Sci Sports Exerc. 2019 Feb;51(2):278-287. doi: 10.1249/MSS.0000000000001778.
- Honka H, Hannukainen JC, Tarkia M, Karlsson H, Saunavaara V, Salminen P, Soinio M, Mikkola K, Kudomi N, Oikonen V, Haaparanta-Solin M, Roivainen A, Parkkola R, Iozzo P, Nuutila P. Pancreatic metabolism, blood flow, and beta-cell function in obese humans. J Clin Endocrinol Metab. 2014 Jun;99(6):E981-90. doi: 10.1210/jc.2013-4369. Epub 2014 Feb 14.
- Salminen P, Gronroos S, Helmio M, Hurme S, Juuti A, Juusela R, Peromaa-Haavisto P, Leivonen M, Nuutila P, Ovaska J. Effect of Laparoscopic Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass on Weight Loss, Comorbidities, and Reflux at 10 Years in Adult Patients With Obesity: The SLEEVEPASS Randomized Clinical Trial. JAMA Surg. 2022 Aug 1;157(8):656-666. doi: 10.1001/jamasurg.2022.2229.
- Gronroos S, Helmio M, Juuti A, Tiusanen R, Hurme S, Loyttyniemi E, Ovaska J, Leivonen M, Peromaa-Haavisto P, Maklin S, Sintonen H, Sammalkorpi H, Nuutila P, Salminen P. Effect of Laparoscopic Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass on Weight Loss and Quality of Life at 7 Years in Patients With Morbid Obesity: The SLEEVEPASS Randomized Clinical Trial. JAMA Surg. 2021 Feb 1;156(2):137-146. doi: 10.1001/jamasurg.2020.5666.
- Pham TT, Ivaska KK, Hannukainen JC, Virtanen KA, Lidell ME, Enerback S, Makela K, Parkkola R, Piirola S, Oikonen V, Nuutila P, Kiviranta R. Human Bone Marrow Adipose Tissue is a Metabolically Active and Insulin-Sensitive Distinct Fat Depot. J Clin Endocrinol Metab. 2020 Jul 1;105(7):2300-10. doi: 10.1210/clinem/dgaa216.
- Salminen 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.
- Immonen H, Hannukainen JC, Iozzo P, Soinio M, Salminen P, Saunavaara V, Borra R, Parkkola R, Mari A, Lehtimaki T, Pham T, Laine J, Karja V, Pihlajamaki J, Nelimarkka L, Nuutila P. Effect of bariatric surgery on liver glucose metabolism in morbidly obese diabetic and non-diabetic patients. J Hepatol. 2014 Feb;60(2):377-83. doi: 10.1016/j.jhep.2013.09.012. Epub 2013 Sep 20.
- Tuulari JJ, Karlsson HK, Hirvonen J, Hannukainen JC, Bucci M, Helmio M, Ovaska J, Soinio M, Salminen P, Savisto N, Nummenmaa L, Nuutila P. Weight loss after bariatric surgery reverses insulin-induced increases in brain glucose metabolism of the morbidly obese. Diabetes. 2013 Aug;62(8):2747-51. doi: 10.2337/db12-1460. Epub 2013 Mar 14. Erratum In: Diabetes. 2017 Oct;66(10 ):2724.
Datas de registro do estudo
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Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
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- SLEEVEPASS
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