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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Helsinki, Finland
- Helsinki university hospital
-
Turku, Finland, 20520
- Department of Surgery, Turku University Central Hospital
-
Turku, Finland
- Turku University Hospital, PET-center
-
Vaasa, Finland
- Vaasa Central Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Sleeve
|
|
Bypass
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Excessive weight loss
Tidsramme: 3,6,12,18 months, 2,3,5,7,10,15 years
|
3,6,12,18 months, 2,3,5,7,10,15 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Resolution of comorbidities
Tidsramme: 3,6,12,18 months, 2,3,5,7,10,15 years
|
3,6,12,18 months, 2,3,5,7,10,15 years
|
|
Mortality
Tidsramme: 0 - 15 years
|
0 - 15 years
|
|
Morbidity
Tidsramme: 0 - 15 years
|
0 - 15 years
|
|
QOL (15D and BAROS)
Tidsramme: 3,6,12,18 months, 2,3,5,7,10,15 years
|
3,6,12,18 months, 2,3,5,7,10,15 years
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Mikael Victorzon, MD, PhD, Vaasa Central Hospital, Vaasa, Finland
- Ledende efterforsker: Paulina Salminen, MD, PhD, Turku Univeristy Central Hospital
- Ledende efterforsker: Jari Ovaska, Md, PhD, University of Turku
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SLEEVEPASS
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .