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Sponsor study identifier
observational
35
1 country
2
Study Start
June 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Non-alcoholic fatty liver disease (NAFLD) is the most common form of chronic liver disease. In the absence of chronic alcohol abuse or other liver diseases, NAFLD incorporates a wide spectrum of liver pathologies and is defined by fatty infiltration of the liver (simple hepatosteatosis). It can progress to non-alcoholic steatohepatitis (NASH) and later fibrosis, cirrhosis, and eventually some patients may develop hepatocellular carcinoma with or without cirrhosis. The exact cause of NAFLD is yet to be cleared and it is, therefore, an active area for research. The diagnosis of NAFLD is achieved through histological examination of liver biopsies (invasive), non-invasive markers using serum biomarkers and imaging techniques are still under development. Pathological diagnosis can be then subcategorized based on several scoring systems. More widely used are the Brunt Score or NAS (NAFLD activity score) and the Kleiner's modified NAS. Obesity is highly associated with NAFLD, as the epidemic of obesity has made NAFLD more prevalent. In addition insulin resistance has been linked to NAFLD and this is explained by the increased influx of free fatty acids (FFAs) into the liver. FFA undergoes either β-oxidation or esterification with glycerol to form triglycerides (TGs), resulting in an additional source of fat in the liver. Due to the strong association of NAFLD with obesity, weight reduction procedures are used for the management of NAFLD. In fact, this has been shown to be effective by several studies. However, other studies have reported liver deterioration after bariatric intervention. This conflict is what makes the effects of bariatric procedures a challenging field for further studies. Consequently in this study we are aimed to examine histologic, metabolic and liver function changes induced by the different therapeutic bariatric procedures.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 27, 2012
Actual (reported)June 2012
Date type not reportedThis date has not been verified as actual or estimated.
June 14, 2012
Actual (reported)July 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Assessment of NAFLD histological changes after bariatric surgery (adjustable gastric banding, sleeve gastrectomy, gastric bypass, and duodenal switch).
Histological evaluation is done by applying the NAFLD activity score (NAS). The stage of fibrosis will be determined by the five-point (stage 0 to 4) scale.
Intra-operatively, 3 months and 1 year postoperatively.
Assessment of liver function after bariatric surgery.
Preoperatively, 3 months, 6 months, 1 year and annually for 5 year postoperatively.
Assessment of NAFLD associated morbidities by detecting the systemic inflammatory changes after bariatric surgery.
preoperatively, 3 months, 6 months, 1 year and annually for 5 year postoperatively.
Assessment of NAFLD associated morbidities by detecting the local inflammatory changes after bariatric surgery.
Baseline (tissues obtained intraoperatively).
Assessment of NAFLD associated morbidities by detecting the metabolic changes after bariatric surgery.
Preoperative, 3 months, 6 months, 1 year and annually for 5 years postoperatively.
Assessment of NAFLD associated morbidities by detecting the endothelial changes after bariatric surgery.
Preoperative, 6 months, 1, 2 and 5 years postoperatively.
As the number of patients dropping out during follow-up, we had difficulty achieving our secondary outcomes, and so the team decided to continue the recruitment until all our outcomes are reached. Main part of the primary outcomes is finalised and published The effects of bariatric surgeries on nonalcoholic fatty liver disease. Aldoheyan T, Hassanain M, Al-Mulhim A, Al-Sabhan A, Al-Amro S, Bamehriz F, Al-Khalidi H. Surg Endosc. 2016 Jul 12
NAFLD patients
King Khalid University Hospital
Riyadh, 7805, Saudi Arabia
Beymer C, Kowdley KV, Larson A, Edmonson P, Dellinger EP, Flum DR. Prevalence and predictors of asymptomatic liver disease in patients undergoing gastric bypass surgery. Arch Surg. 2003 Nov;138(11):1240-4. doi: 10.1001/archsurg.138.11.1240.
Gholam PM, Kotler DP, Flancbaum LJ. Liver pathology in morbidly obese patients undergoing Roux-en-Y gastric bypass surgery. Obes Surg. 2002 Feb;12(1):49-51. doi: 10.1381/096089202321144577.
Blood (serum, plasma, and RNA isolate) Liver core biopsy Subcutaneous fat Visceral fat Abdominal wall muscle
Dr.Mazen Hassanain, MBBS FRCSC PhD
King Khalid University Hospital,King Saud University,Riyadh,KSA.
First Submitted
May 27, 2012
First Posted
June 14, 2012
Study Start
June 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2018
Contact the study team to confirm eligibility.
King Khalid University Hospital
Riyadh, 7805, Saudi Arabia
Oliveira CP, Faintuch J, Rascovski A, Furuya CK Jr, Bastos Mdo S, Matsuda M, Della Nina BI, Yahnosi K, Abdala DS, Vezozzo DC, Alves VA, Zilberstein B, Garrido AB Jr, Halpern A, Carrilho FJ, Gama-Rodrigues JJ. Lipid peroxidation in bariatric candidates with nonalcoholic fatty liver disease (NAFLD) -- preliminary findings. Obes Surg. 2005 Apr;15(4):502-5. doi: 10.1381/0960892053723493.
Frantzides CT, Carlson MA, Moore RE, Zografakis JG, Madan AK, Puumala S, Keshavarzian A. Effect of body mass index on nonalcoholic fatty liver disease in patients undergoing minimally invasive bariatric surgery. J Gastrointest Surg. 2004 Nov;8(7):849-55. doi: 10.1016/j.gassur.2004.07.001.
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Spaulding L, Trainer T, Janiec D. Prevalence of non-alcoholic steatohepatitis in morbidly obese subjects undergoing gastric bypass. Obes Surg. 2003 Jun;13(3):347-9. doi: 10.1381/096089203765887633.
Moretto M, Kupski C, Mottin CC, Repetto G, Garcia Toneto M, Rizzolli J, Berleze D, de Souza Brito CL, Casagrande D, Colossi F. Hepatic steatosis in patients undergoing bariatric surgery and its relationship to body mass index and co-morbidities. Obes Surg. 2003 Aug;13(4):622-4. doi: 10.1381/096089203322190853.
Silverman EM, Sapala JA, Appelman HD. Regression of hepatic steatosis in morbidly obese persons after gastric bypass. Am J Clin Pathol. 1995 Jul;104(1):23-31. doi: 10.1093/ajcp/104.1.23.
Dixon JB, Bhathal PS, Hughes NR, O'Brien PE. Nonalcoholic fatty liver disease: Improvement in liver histological analysis with weight loss. Hepatology. 2004 Jun;39(6):1647-54. doi: 10.1002/hep.20251.
Blackburn GL, Mun EC. Effects of weight loss surgeries on liver disease. Semin Liver Dis. 2004 Nov;24(4):371-9. doi: 10.1055/s-2004-860866.
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Vandanmagsar B, Youm YH, Ravussin A, Galgani JE, Stadler K, Mynatt RL, Ravussin E, Stephens JM, Dixit VD. The NLRP3 inflammasome instigates obesity-induced inflammation and insulin resistance. Nat Med. 2011 Feb;17(2):179-88. doi: 10.1038/nm.2279. Epub 2011 Jan 9.
DeFronzo RA, Tobin JD, Andres R. Glucose clamp technique: a method for quantifying insulin secretion and resistance. Am J Physiol. 1979 Sep;237(3):E214-23. doi: 10.1152/ajpendo.1979.237.3.E214.
Hompesch M, Rave K. An analysis of how to measure glucose during glucose clamps: are glucose meters ready for research? J Diabetes Sci Technol. 2008 Sep;2(5):896-8. doi: 10.1177/193229680800200522.
Mathurin P, Gonzalez F, Kerdraon O, Leteurtre E, Arnalsteen L, Hollebecque A, Louvet A, Dharancy S, Cocq P, Jany T, Boitard J, Deltenre P, Romon M, Pattou F. The evolution of severe steatosis after bariatric surgery is related to insulin resistance. Gastroenterology. 2006 May;130(6):1617-24. doi: 10.1053/j.gastro.2006.02.024.
Mathurin P, Hollebecque A, Arnalsteen L, Buob D, Leteurtre E, Caiazzo R, Pigeyre M, Verkindt H, Dharancy S, Louvet A, Romon M, Pattou F. Prospective study of the long-term effects of bariatric surgery on liver injury in patients without advanced disease. Gastroenterology. 2009 Aug;137(2):532-40. doi: 10.1053/j.gastro.2009.04.052. Epub 2009 May 4.
Moschen AR, Molnar C, Geiger S, Graziadei I, Ebenbichler CF, Weiss H, Kaser S, Kaser A, Tilg H. Anti-inflammatory effects of excessive weight loss: potent suppression of adipose interleukin 6 and tumour necrosis factor alpha expression. Gut. 2010 Sep;59(9):1259-64. doi: 10.1136/gut.2010.214577. Epub 2010 Jul 21.
Phillips ML, Boase S, Wahlroos S, Dugar M, Kow L, Stahl J, Slavotinek JP, Valentine R, Toouli J, Thompson CH. Associates of change in liver fat content in the morbidly obese after laparoscopic gastric banding surgery. Diabetes Obes Metab. 2008 Aug;10(8):661-7. doi: 10.1111/j.1463-1326.2007.00793.x. Epub 2007 Oct 17.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 30, 2018
Record last verified: 2018-03
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