The 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.

The 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. - FAT trial (Fatty Acids Treatment trial)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36714

Enrollment

Registered

2011-10-25

Start date

2011-12-01

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fatty liver non-alcoholic fatty liver disease

Interventions

Eucaloric diet with high dose omega-3 fatty acids (Supportan®) vs eucaloric diet without omega-3 fatty acids (Fresubin®) 4 weeks prior to laparoscopic Roux-Y gastic bypass surgery.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: MRS suggesting NAFLD 18-65 years of age Morbid obesity Ability to provide informed consent. Stable weight 2 months prior to inclusion

Exclusion criteria

Exclusion criteria: Use of lipid lowering drugs (i.e., statins and fibrate drugs) Any medical condition execpt for hypertension, dyslipidemia, glucose intolerance, treated hypothyroidism, coagulation disorders (increased bleeding time PT, aPTT) Excessive alcohol intake - > > 14 units/week Contraindications to MR scanning - pacemaker or metallic foreign body, claustrophobia etc. Use of n-3 PUFA supplements within the prior 4 months, Pregnancy, females who are breastfeeding.

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
1. Liver volume (hoe meet je die?) 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	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)