title: N-3 fatty acids do not lead to an increased diabetic risk in patients with hyperlipidemia and abnormal glucose tolerance. Italian Fish Oil Multicenter Study.
abstract: A multicenter, randomized, double-blind, place-bo-controlled study evaluated the possible worsening of glycemic control after a moderate daily intake of n-3 fatty acid ethyl esters in patients with hypertriglyceridemia with and without glucose intolerance or diabetes. A total of 935 patients of both sexes in 63 Italian clinical centers were selected; 55% had either impaired glucose tolerance or non-insulin-dependent diabetes mellitus (NIDDM). They received for 2 mo either 1 g n-3 ethyl esters three times a day or a corresponding placebo, followed by 4 mo of either 1 g n-3 ethyl esters twice a day or placebo. In addition to the complete lipid and lipoprotein evaluation, patients with impaired glucose tolerance also underwent an oral-glucose-tolerance test; in patients with NIDDM, serum insulin and glycated hemoglobin (Hb A1c) concentrations were determined. Plasma triacylglycerol concentrations decreased significantly, up to 21.53% at 6 mo compared with baseline (decreased 15% compared with placebo), with a tendency toward a progressive reduction with time. There was no evidence for a different response in patients with either NIDDM or impaired glucose tolerance. Among NIDDM patients, the triacylglycerol reduction was greater in those with high-density-lipoprotein cholesterol < or = 0.91 mmol/L. There was no alteration in the major glycemic indexes: fasting glucose, Hb A1c, insulinemia, and oral glucose tolerance in patients with impaired glucose tolerance or NIDDM after treatment with n-3 ethyl esters. Treatment with a moderate daily dose of n-3 ethyl esters over a prolonged period of time significantly reduced triacylglycerol concentrations without any worsening of glucose tolerance in patients with hypertriglyceridemia with and without impaired glycemic regulation.
authors.affiliation: University of Milano, Center E Grossi Paoletti, Institute of Pharmacological Science, Italy. Sirtori@isfunix.farma.unimi.it
authors.forename: C R
authors.initials: CR
authors.lastname: Sirtori
authors.forename: R
authors.initials: R
authors.lastname: Paoletti
authors.forename: M
authors.initials: M
authors.lastname: Mancini
authors.forename: G
authors.initials: G
authors.lastname: Crepaldi
authors.forename: E
authors.initials: E
authors.lastname: Manzato
authors.forename: A
authors.initials: A
authors.lastname: Rivellese
authors.forename: F
authors.initials: F
authors.lastname: Pamparana
authors.forename: E
authors.initials: E
authors.lastname: Stragliotto
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000032:analysis; D008076:Cholesterol, HDL / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000453:epidemiology* / Q000378:metabolism / Q000503:physiopathology*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D015525:Fatty Acids, Omega-3 / Q000008:administration & dosage / Q000097:blood / Q000494:pharmacology*; D005260:Female; D005947:Glucose / Q000378:metabolism / Q000494:pharmacology*; D005951:Glucose Tolerance Test; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D006949:Hyperlipidemias / Q000097:blood / Q000503:physiopathology*; D006973:Hypertension / Q000503:physiopathology; D007328:Insulin / Q000097:blood; D007333:Insulin Resistance / Q000502:physiology; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D012307:Risk Factors
chemical_list: D001786:Blood Glucose; D008076:Cholesterol, HDL; D015525:Fatty Acids, Omega-3; D005947:Glucose; D006442:Glycated Hemoglobin; D007328:Insulin; D008055:Lipids