Obesity, MorbidNCT01619215
The Effects of Bariatric Surgeries on Non-Alcoholic Fatty Liver Disease
An observational study of Obesity, Morbid and Non-Alcoholic Fatty Liver Disease, run by King Saud University at 2 sites in Saudi Arabia.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Morbid, Non-Alcoholic Fatty Liver Disease
- How many people
- 35 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- Jun 2012to Jul 2018
- Phase
- Observational
- 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
Study population: NAFLD patients
Who may be able to join
- Age between 18 to 60 years.
- Eligible for obesity surgery according to the following criteria:
- BMI > 30 kg/m2.
- Ability to demonstrate eating habit control by reducing 10% of the original weight prior to surgery
- Pass the nutritional and the psychological assessment
- Pass the preoperative testing to determine the operative risk
- Ultrasound diagnosis of NAFLD prior to surgery.
- Written informed consent.
Who cannot join
- Unwilling to take part in the study, or asked to be removed from the study at any time.
- History of alcohol intake > 20 g/day for 5 or more years
- Evidence autoimmune hepatitis, chronic hepatitis B or C virus, HIV, genetic hemochromatosis, alpha-1 antitrypsin deficiency, Wilson disease, or cirrhosis.
- Pregnancy.
- Currently taking known hepatotoxic medications.
- Failure to attend follow-up for a minimum of 1 year.
- Non-Saudi patients
Trial locations and contacts
2 sites in 1 country.
Saudi Arabia2 sites, 2 recruiting
- Recruiting
King Khalid University Hospital
Riyadh, 7805
Tamader AlDoheyan, (MBBSc), +966500083720, AlDoheyan.Tamader@gmail.com
Maram AlKhamash, +966548327049, Malkhamash.c@KSU.EDU.SA
- Recruiting
King Khalid University Hospital
Riyadh, 7805
Tamader Al-Doheyan, (MBBSc), +966500083720, AlDoheyan.Tamader@gmail.com
Maram AlKhamash, +966548327049, Malkhamash.c@KSU.EDU.SA
About this study
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.
Read the detailed description
35 consecutive patients referred for bariatric surgery will be recruited either at the obesity clinic, or from inpatient (scheduled for bariatric surgery). A detailed history and a complete physical examination will be done at the first visit along with anthropometric measures; routine blood tests, liver function, hormonal assessment, and certain metabolic and inflammatory markers will be evaluated. They will also have an abdominal ultrasound for initial NAFLD assessment, fibroscan to detect liver fibrosis, and an MRI to measure hepatic fat content and body fat composition including intra-abdominal and extra-abdominal fat. These patients will be asked to lose a certain amount of kilos (depending on their BMI and the surgeon preference) out of their original weight, in order to become candidates for bariatric surgery at King Saud University Hospital (KKUH).
At the second visit, (if they lose the recommended amount weight) we will assess their weight loss; obtain blood for the same hormonal and inflammatory markers assessment. Nonetheless, if they did not lose weight and the treating surgeon gave them a third appointment, we will consider their third visit as a second visit; preforming all the investigations mentioned above. In this case we will interpret their results with respect to the total duration of "before surgery" weight loss.
During the operation, tissue biopsy will be taken with a core needle biopsy for the liver and a sharp non-thermal instrument for subcutaneous fat, visceral fat, and abdominal muscle immediately after skin incision. A CAP certified tissue manager would process all tissues. Liver biopsy will be sliced it to two parts; the first half is for histological evaluation, but the other half will be stored for tissue studies. The histologic slides will be stained with hematoxylin and eosin (H\&E), and Masson Trichrome stains for microscopic evaluation. This evaluation will be provided by a single histopathologist who will be blinded to the patients' clinical condition, and the order of the biopsy.
Follow Up:
After the surgery follow up appointments will be scheduled 3 months, 6 months, 1 year, and annually till 5 years. The followings will be done in each visit:
- Thorough physical exam as per the CRF.
- Take a blood sample to evaluate liver function, metabolic, and inflammatory changes using the same parameters as those in the baseline.
- Request for: fibroscan and abdominal ultrasound. Second, third and fourth liver biopsies will be taken percutaneously 3 months, 1 year, and 5 years following the initial biopsy respectively. These biopsies will be obtained using core tissue biopsy with ultrasound guidance for the same histological assessment and tissue studies. Another MRI will be schedule 1 year after the surgery.
Specimens collected under this trial will be part of the King Saud University Liver Disease Research Centre Biobanking and will follow all policy and procedures within the biobanking protocol as approved by the IRB committee.
- Conditions
- Obesity, Morbid, Non-Alcoholic Fatty Liver Disease
- Medical subject headings
- Obesity, Morbid, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bariatric Surgery | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intra-operatively, 3 months and 1 year postoperatively.
Secondary outcomes (8)
Assessment of liver function after bariatric surgery.
- Measure serum albumin, bilirubin, INR, anti-thrombin-III, ALT, GGT, AST, protein C and S levels.
- Measure albumin synthesis using radiolabeled amino acids.
Measured: 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.
- Study systemic inflammatory changes by measuring the serum levels of several inflammatory mediators: ESR, C-reactive protein, interleukins (IL-1, IL-4, IL-6, IL-8, IL-10, IL-16), adipokines (adiponectin, leptin, adipsin and Chemerin), MCP1, osteopontin, and growth factors (TNF-α, and VEGF).
Measured: 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.
- Hepatic expression of α-SMA, collagen α1, TGF-β1, MCP-1, IL-6, IL-8, leptin and adiponectin receptors. PAI1, ACRP30, ADIPOQ.
- Visceral adipose tissue to assess the expression of NOD-like receptor pyrin domain-containing-3 inflammasome (Nlrp3); are inflammatory markers that recognize certain signals that leads to caspase-1 activation and subsequent IL-1 and IL-18.
- Subcutaneous adipose tissue to assess the expression of adiponectin, IL-6 and TNF-α.
Measured: Baseline (tissues obtained intraoperatively).
Assessment of NAFLD associated morbidities by detecting the metabolic changes after bariatric surgery.
- Hormonal changes: serum levels of ghrelin, peptide YY, amylin, cholecystokinin, insulin, glucagon, epinephrine, and cortisol.
- Non-hormonal changes: HbA1c, FFA, HDL, cholesterol, triglycerides, fasting glucose.
Measured: 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.
- Doppler Ultrasound (Duplex) for the carotid arteries.
- Measuring the levels of progenitor cells.
Measured: Preoperative, 6 months, 1, 2 and 5 years postoperatively.
Studying the genetic factors expressing for the inflammatory changes differences in responders.
- TMA construction using the formalin stored liver, visceral fat and abdominal wall muscle.
- Detecting mRNA expression from frozen tissue (liver, visceral fat and abdominal wall muscle) with respect of inflammation, insulin action, lipid metabolism, liver regression and apoptosis.
- Deep gene sequencing for subgroup of patients with variables clinical responses or with genetic differences determined form the above testing.
Measured: Baseline (for liver, visceral and subcutaneous fat). Postoperatively (for liver only): 3 months, 1 year and 5 years after the surgery.
Long-term follow-up to examine the correlation between the type of surgery and clinical outcomes associated with NAFLD (liver cirrhosis, incidence of cancer, and mortality).
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.
Measured: 5 years
Testing the efficacy of the non-invasive images in the diagnosis of NAFLD.
- Magnetic Resonance Studies.
- Fibroscan.
- Ultrasound.
Measured: Baseline (preoperatively), 1 year and 5 years postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Obesity, MorbidStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mazen Hassanain, King Saud University
- Investigators
- Dr.Mazen Hassanain, MBBS FRCSC PhD, Principal investigator, King Khalid University Hospital,King Saud University,Riyadh,KSA.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619215
- Sponsor's protocol ID
- KSULDRCBSMH001
- Status last verified
- Mar 2018
- First submitted
- 27 May 2012
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 14609874Gholam 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.
PubMed 11868297Oliveira 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.
PubMed 15946429Frantzides 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.
PubMed 15531238Dixon JB, Bhathal PS, O'Brien PE. Nonalcoholic fatty liver disease: predictors of nonalcoholic steatohepatitis and liver fibrosis in the severely obese. Gastroenterology. 2001 Jul;121(1):91-100. doi: 10.1053/gast.2001.25540.
PubMed 11438497Ruhl CE, Everhart JE. Determinants of the association of overweight with elevated serum alanine aminotransferase activity in the United States. Gastroenterology. 2003 Jan;124(1):71-9. doi: 10.1053/gast.2003.50004.
PubMed 12512031Spaulding 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.
PubMed 12841891Moretto 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.
PubMed 12940291Silverman 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.
PubMed 7611176Dixon 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.
PubMed 15185306Blackburn 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.
PubMed 15605305Grimm IS, Schindler W, Haluszka O. Steatohepatitis and fatal hepatic failure after biliopancreatic diversion. Am J Gastroenterol. 1992 Jun;87(6):775-9.
PubMed 1590319Vandanmagsar 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.
PubMed 21217695DeFronzo 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.
PubMed 382871Hompesch 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.
PubMed 19885275
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Bariatric Surgeries on Non-Alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT01619215
- Acronym / sponsor ID
- KSULDRCBSMH001
- Conditions
- Obesity, Morbid, Non-Alcoholic Fatty Liver Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 14 Jun 2012 (estimated)
- 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.
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.
Detailed description
35 consecutive patients referred for bariatric surgery will be recruited either at the obesity clinic, or from inpatient (scheduled for bariatric surgery). A detailed history and a complete physical examination will be done at the first visit along with anthropometric measures; routine blood tests, liver function, hormonal assessment, and certain metabolic and inflammatory markers will be evaluated. They will also have an abdominal ultrasound for initial NAFLD assessment, fibroscan to detect liver fibrosis, and an MRI to measure hepatic fat content and body fat composition including intra-abdominal and extra-abdominal fat. These patients will be asked to lose a certain amount of kilos (depending on their BMI and the surgeon preference) out of their original weight, in order to become candidates for bariatric surgery at King Saud University Hospital (KKUH).
At the second visit, (if they lose the recommended amount weight) we will assess their weight loss; obtain blood for the same hormonal and inflammatory markers assessment. Nonetheless, if they did not lose weight and the treating surgeon gave them a third appointment, we will consider their third visit as a second visit; preforming all the investigations mentioned above. In this case we will interpret their results with respect to the total duration of "before surgery" weight loss.
During the operation, tissue biopsy will be taken with a core needle biopsy for the liver and a sharp non-thermal instrument for subcutaneous fat, visceral fat, and abdominal muscle immediately after skin incision. A CAP certified tissue manager would process all tissues. Liver biopsy will be sliced it to two parts; the first half is for histological evaluation, but the other half will be stored for tissue studies. The histologic slides will be stained with hematoxylin and eosin (H\&E), and Masson Trichrome stains for microscopic evaluation. This evaluation will be provided by a single histopathologist who will be blinded to the patients' clinical condition, and the order of the biopsy.
Follow Up:
After the surgery follow up appointments will be scheduled 3 months, 6 months, 1 year, and annually till 5 years. The followings will be done in each visit:
- Thorough physical exam as per the CRF.
- Take a blood sample to evaluate liver function, metabolic, and inflammatory changes using the same parameters as those in the baseline.
- Request for: fibroscan and abdominal ultrasound. Second, third and fourth liver biopsies will be taken percutaneously 3 months, 1 year, and 5 years following the initial biopsy respectively. These biopsies will be obtained using core tissue biopsy with ultrasound guidance for the same histological assessment and tissue studies. Another MRI will be schedule 1 year after the surgery.
Specimens collected under this trial will be part of the King Saud University Liver Disease Research Centre Biobanking and will follow all policy and procedures within the biobanking protocol as approved by the IRB committee.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bariatric Surgery | – | –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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- NAFLD patients
Key inclusion criteria (8 listed)
- Age between 18 to 60 years.
- Eligible for obesity surgery according to the following criteria:
- Ultrasound diagnosis of NAFLD prior to surgery.
- Written informed consent.
Key exclusion criteria (7 listed)
- Unwilling to take part in the study, or asked to be removed from the study at any time.
- History of alcohol intake > 20 g/day for 5 or more years
- Evidence autoimmune hepatitis, chronic hepatitis B or C virus, HIV, genetic hemochromatosis, alpha-1 antitrypsin deficiency, Wilson disease, or cirrhosis.
- Pregnancy.
- Currently taking known hepatotoxic medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of NAFLD histological changes after bariatric surgery (adjustable gastric banding, sleeve gastrectomy, gastric bypass, and duodenal switch).
Time frame: Intra-operatively, 3 months and 1 year postoperatively.
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.
8 secondary outcomes
Assessment of liver function after bariatric surgery.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (tissues obtained intraoperatively).
Assessment of NAFLD associated morbidities by detecting the metabolic changes after bariatric surgery.
Time frame: 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.
Time frame: Preoperative, 6 months, 1, 2 and 5 years postoperatively.
Studying the genetic factors expressing for the inflammatory changes differences in responders.
Time frame: Baseline (for liver, visceral and subcutaneous fat). Postoperatively (for liver only): 3 months, 1 year and 5 years after the surgery.
Long-term follow-up to examine the correlation between the type of surgery and clinical outcomes associated with NAFLD (liver cirrhosis, incidence of cancer, and mortality).
Time frame: 5 years
Testing the efficacy of the non-invasive images in the diagnosis of NAFLD.
Time frame: Baseline (preoperatively), 1 year and 5 years postoperatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Background: PubMed 14609874Beymer 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.
- Background: PubMed 11868297Gholam 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.
- Background: PubMed 15946429Oliveira 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.
- Background: PubMed 15531238Frantzides 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.
- Background: PubMed 11438497Dixon JB, Bhathal PS, O'Brien PE. Nonalcoholic fatty liver disease: predictors of nonalcoholic steatohepatitis and liver fibrosis in the severely obese. Gastroenterology. 2001 Jul;121(1):91-100. doi: 10.1053/gast.2001.25540.
- Background: PubMed 12512031Ruhl CE, Everhart JE. Determinants of the association of overweight with elevated serum alanine aminotransferase activity in the United States. Gastroenterology. 2003 Jan;124(1):71-9. doi: 10.1053/gast.2003.50004.
- Background: PubMed 12841891Spaulding 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.
- Background: PubMed 12940291Moretto 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.
- Background: PubMed 7611176Silverman 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.
- Background: PubMed 15185306Dixon 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.
- Background: PubMed 15605305Blackburn 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.
- Background: PubMed 1590319Grimm IS, Schindler W, Haluszka O. Steatohepatitis and fatal hepatic failure after biliopancreatic diversion. Am J Gastroenterol. 1992 Jun;87(6):775-9.
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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.
Dr.Mazen Hassanain, MBBS FRCSC PhD principal investigator
King Khalid University Hospital,King Saud University,Riyadh,KSA.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid and Non-Alcoholic Fatty Liver Disease, run by King Saud University at 2 sites in Saudi Arabia.
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 8 inclusion and 7 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 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. 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?
Contact Manal Hassan, BPharm (+966566905250, ManHassan.c@KSU.EDU.SA), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of NAFLD histological changes after bariatric surgery (adjustable gastric banding, sleeve gastrectomy, gastric bypass, and duodenal switch). (time frame: Intra-operatively, 3 months and 1 year postoperatively.). 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 NCT01619215, which also lists 19 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 30 Mar 2018.