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Effects of omega-3 fatty acids on fatty liver and insulin sensitivity.


- candidate number9294
- NTR NumberNTR2836
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-apr-2011
- Secondary IDs 
- Public TitleEffects of omega-3 fatty acids on fatty liver and insulin sensitivity.
- Scientific TitleThe effects of 4 weeks oral administration of omega-3 fatty acids on hepatic steatosis and insulin sensitivity in morbidly obese patients undergoing gastric bypass surgery.
- ACRONYMFAT trial (Fatty Acids Treatment trial)
- hypothesisHigh dose of oral administration of omega-3 fatty acids ameliorates hepatic steatosis and insulin sensitivity in morbidly obese patients undergoing LRYGBP.
- Healt Condition(s) or Problem(s) studiedHepatic steatosis, Insulin sensitivy, Morbid obesity , Non alcoholic steato hepatitis (NASH), Omega-3 fatty acids
- Inclusion criteria1. MRS suggesting NAFLD;
2. 18-65 years of age;
3. IFSO criteria;
4. Ability to provide informed consent;
5. Stable weight 2 months prior to inclusion.
- Exclusion criteria1. Use of lipid lowering drugs (i.e., statins and fibrate drugs);
2. Any medication except anti-hypertensives, levothyroxine, OAC;
3. Any medical condition execpt for hypertension, dyslipidemia, glucose intolerance, treated hypothyroidism, coagulation disorders (increased bleeding time PT, aPTT);
4. Excessive alcohol intake - > > 14 units/week;
5. Contraindications to MR scanning - pacemaker or metallic foreign body, claustrophobia etc;
6. Use of n-3 PUFA supplements within the prior 4 months;
7. Current use of weight loss medication;
8. Pregnancy, females who are breastfeeding;
9. Renal insufficiency (creatinine > 150 umol/L);
10. History of jejunal-ileal bypass or extensive small bowel resection.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2011
- planned closingdate31-dec-2012
- Target number of participants20
- InterventionsEucaloric diet with high dose omega-3 fatty acids (SupportanŽ) vs. eucaloric diet without omega-3 fatty acids (FresubinŽ) 4 weeks prior to laparoscopic Roux-Y gastic bypass surgery.
- Primary outcome1. To assess the effects of omega-3 fatty acids on hepatic steatosis;
2. To assess the effects of omega-3 fatty acids on hepatic and peripheral insulin resistance.
- Secondary outcome1. Liver volume;
2. Fatty acids in the basal state and during hyperinsulinemia;
3. Plasma lipid profile;
4. Hepatic lipid profile;
5. Resting energy expenditure (REE);
6. Differences in expression profiles in liver tissue;
7. Histological classification of hepatic steatosis;
8. Changes in circulating inflammatory proteins.
- Timepoints1. MRS liver + clamp pre-diet and post-diet;
2. Liverbiopsy post-diet during operation.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. A. Schigt
- CONTACT for SCIENTIFIC QUERIES M.J.M. Serlie
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryBackground of the study:
Hepatic steatosis is characterized by excessive triglyceride accumulation in the liver which is caused by either excessive import, diminished export and/or impaired beta-oxidation of fatty acids. Without treatment, simple steatosis (non-alcoholic fatty liver disease, NAFLD) may progress to an inflammatory state (non-alcoholic steatohepatitis, NASH) and ultimately fibrosis, cirrhosis and hepatocellular carcinoma (HCC). The prevalence of NAFLD in industrialized populations ranges from 20-40%. NAFLD is directly linked to obesity/the metabolic syndrome and with the epidemic growth of obesity, a higher incidence of NAFLD is expected. Weight loss is the most effective treatment strategy for hepatic steatosis. Permanent weight loss in morbidly obese subjects can only be reached by bariatric surgery. However, enlarged steatotic livers may complicate surgery as in case of laparoscopic gastric bypass surgery it diminishes technical maneuverability in the gastroesophageal area. In addition, steatotic livers seem to be more vulnerable to complications caused by direct liver tissue damage when the liver is mobilized or retracted during operation. Therefore it may be of clinical benefit to reduce the degree of hepatic steatosis. In a rat model of hepatic steatosis, we recently showed that supplementation of omega-3 fatty acids significantly reduced TG accumulation in the liver (Marsman et al, submitted). Fatty acids are activators of some nuclear receptors involved in beta-oxidation, but until now it is not completely unraveled whether and how omega-3 fatty acid supplementation affects hepatic steatosis in humans.

Objective of the study:
The aim of this study is to evaluate the effect of supplementation of a high oral dose of omega-3 fatty acids on hepatic steatosis and glucose metabolism in morbidly obese patients undergoing laparoscopic Roux-Y gastric bypass surgery (LRYGBP).

Study design:
Randomized controlled intervention study.

Study population:
Morbidly obese subjects scheduled for bariatric surgery, 18-65 years old.

Intervention:
Eucaloric diet with high dose omega-3 fatty acids (SupportanR) vs eucaloric diet without omega-3 fatty acids (FresubinR) 4 weeks prior to laparoscopic Roux-Y gastic bypass surgery.

Primary study parameters/outcome of the study:
1. To assess the effects of omega-3 fatty acids on hepatic steatosis;
2. To assess the effects of omega-3 fatty acids on hepatic and peripheral insulin resistance.

Secundary study parameters/outcome of the study:
1. Liver volume;
2. Fatty acids in the basal state and during hyperinsulinemia;
3. Plasma lipid profile;
4. Hepatic lipid profile;
5. Resting energy expenditure (REE);
6. Differences in expression profiles in liver tissue;
7. Histological classification of hepatic steatosis;
8. Changes in circulating inflammatory proteins.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Biometric data such as waist circumference, BMI and blood pressure will be measured. During surgery biopsies will be taken from visceral and abdominal subcutaneous adipose tissue and the liver. The risks of bleeding from the biopsy sites during the bariatric surgery procedure are very small because the biopsy sites are completely visible to the surgeon and local hemostasis will be checked. Subjects will visit the research unit weekly during the study; total visit time will be about 34 hours. In addition an MRS of the liver will be performed to quantify liver fat content. The MRS-scan requires lying still as possible for 45 minutes. Subjects will undergo a 2-step hyperinsulinemic euglycemic clamp using stable isotopes before and after the diet period to study glucose metabolism. For the administration of the stable isotope, glucose and insulin and for blood sampling, intravenous canules will be inserted in the left and right antecubital vein. Stable isotopes are not harmful and hypoglycaemia will not occur because glucose is monitored every 5 minutes. Total clamping time on one day will be 7 hours.
- Main changes (audit trail)
- RECORD1-apr-2011 - 11-apr-2011


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