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

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26624

Enrollment

Registered

2011-04-01

Start date

2011-05-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

non-alcoholic fatty liver disease (NAFLD) hepatic steatosis insulin sensitivity morbid obesity omega-3 fatty acids

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

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: 1. 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.

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; 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.	—

Contacts

Public ContactA. Schigt

Department of Surgery, Surgical Laboratory, IWO 1-155 Department of Endocrinology & Metabolism, F5-165 Academic Medical Center, Amsterdam Meibergdreef 9

a.schigt@amc.nl+31 (0)20 5663507

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)