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Study Title and Description

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.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
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.
Author Sirtori CR., Paoletti R., Mancini M., Crepaldi G., Manzato E., Rivellese A., Pamparana F., Stragliotto E.
Country University of Milano, Center E Grossi Paoletti, Institute of Pharmacological Science, Italy. Sirtori@isfunix.farma.unimi.it
Year 1997
Numbers Pubmed ID: 9174486
16827 (internal)

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 All n-3 PUFAs (ALA+DHA+EPA) 6 month open phase
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2 Placebo 6 month open phase
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Parallel (Omega-3 vs. Control; Omega-3 + X vs. X)
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Country in which study conducted (where subjects live) Italy
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Funding source Industry funded
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Eligibility Criteria: The study protocol allowed the selection of patients of both sexes, males aged 45-75 y and females aged 55-80 y, with hyperlipoproteinemias type IIB or IV (23) associated with at least one additional risk factor: impaired glucose tolerance, NIDDM, or arterial hypertension. Patients with severe intercurrent ailments, kidney or renal disease, intestinal malabsorption, duodenal ulcer not responsive to therapy, obese individuals with a body mass index (in kg/m2)  30, as well as noncompliant or unreliable patients were excluded from the study. All patients with a history of vascular or nonvascular brain disease (including epilepsy and alcoholism), severe hyperlipidemia needing drug treatment, severe hypertension (DBP > 1 10 mm Hg, SBP > 180 mm Hg under antihypertensive treatment), myocardial infarction in the preceding 3 mo, or unstable angina were excluded.
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Comment about Eligibility Criteria: 1995 (approx)
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Study Population Primary Prevention, Increased CVD Risk (ie, diabetes, metabolic syndrome*, hypertension, dyslipidemia, or chronic kidney disease)
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Duration of Intervention 6 month
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At baseline, did all subjects have (per eligibility criteria)...? Diabetes and/or metabolic syndrome*
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Hypertension ... Patients treated with antihypertensive drugs or who on more than one occasion in the past year had had a systolic blood pressure (SBP)  160 mm Hg, a diastolic blood pressure (DBP)  95 mm Hg, or both, independent of drug treatment, were considered to have arterial hypertension.
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Dyslipidemia ... Patients with significant and stable triacylglycerol elevations (> 2.26 mmollL, or 200 mg/dL) were selected. These were defined as type IIB if serum total cholesterol was > 7.21 mmol/L (270 mg/dL) and type IV if cholesterol was ı 7.21 mmol/L (270 mg/dL). Patients with total cholesterol concentrations > 7.76 mmollL (300 mg/dL) with triacylglycerol concentrations  4.52 mmolIL (400 mg/dL) were excluded for ethical reasons.
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Other ... Impaired glucose tolerance
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Conflict of interest No Data regarding conflict of interest
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Does the study report a subgroup analysis for an outcome of interest? ... Which subgroups? Yes ... HDL concentration (<=0.91 and >0.91 mmol/L) in all patients and NIDDM patients
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Does the study report a regression analysis with interaction terms for an outcome of interest? No
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Does the study report an analysis of the association between n-3 biomarkers and an outcome of interest? No
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Baseline Characteristics
Question All n-3 PUFAs (ALA+DHA+EPA) Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 44 45
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Patients who had been diagnosed as having diabetes for  2 y, who were in satisfactory metabolic control with or without pharmacologic treatment (fasting glucose < 7.7 nmolIL, or 140 mg/dL, and postprandial glucose < 1 1 . 1 nmollL, or 200 mg/ dL) were defined as having NIDDM. Patients taking insulin were excluded. Patients who had been diagnosed as having diabetes for  2 y, who were in satisfactory metabolic control with or without pharmacologic treatment (fasting glucose < 7.7 nmolIL, or 140 mg/dL, and postprandial glucose < 1 1 . 1 nmollL, or 200 mg/ dL) were defined as having NIDDM. Patients taking insulin were excluded.
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100 100
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Patients with significant and stable triacylglycerol elevations (> 2.26 mmollL, or 200 mg/dL) were selected. These were defined as type IIB if serum total cholesterol was > 7.21 mmol/L (270 mg/dL) and type IV if cholesterol was ı 7.21 mmol/L (270 mg/dL). Patients with total cholesterol concentrations > 7.76 mmollL (300 mg/dL) with triacylglycerol concentrations  4.52 mmolIL (400 mg/dL) were excluded for ethical reasons. Patients with significant and stable triacylglycerol elevations (> 2.26 mmollL, or 200 mg/dL) were selected. These were defined as type IIB if serum total cholesterol was > 7.21 mmol/L (270 mg/dL) and type IV if cholesterol was ı 7.21 mmol/L (270 mg/dL). Patients with total cholesterol concentrations > 7.76 mmollL (300 mg/dL) with triacylglycerol concentrations  4.52 mmolIL (400 mg/dL) were excluded for ethical reasons.
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68 68
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Patients treated with antihypertensive drugs or who on more than one occasion in the past year had had a systolic blood pressure (SBP)  160 mm Hg, a diastolic blood pressure (DBP)  95 mm Hg, or both, independent of drug treatment, were considered to have arterial hypertension Patients treated with antihypertensive drugs or who on more than one occasion in the past year had had a systolic blood pressure (SBP)  160 mm Hg, a diastolic blood pressure (DBP)  95 mm Hg, or both, independent of drug treatment, were considered to have arterial hypertension
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0 0
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MI in the preceding 3 months MI in the preceding 3 months
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Baseline characteristics, continuous 58.2 58.8
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skip skip
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9.09 8.99
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nd nd
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nd nd
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nd nd
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nd nd
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nd nd
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nd nd
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nd nd
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nd nd
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74.0 73.7
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Kg Kg
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10.44 10.08
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Male, percent 62.6 62.2
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Race nd nd nd
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Comments about baseline data No data entered.
Baseline diet description The start of the active treatment or placebo period was preceded by a run-in and wash-out period of  4 wk, during which patients followed an isoenergetic diet to maintain a stable body weight.
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Baseline omega-3 intake nd nd nd
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Does this study report baseline omega-3 biomarker data? No No No
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Results & Comparisons


Results Data
Outcome: lipid      Population: 51889
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) Placebo


0 months

N Analyzed 470 465
Mean 1.03 1.03
SE 0.02 0.02


2 months

N Analyzed 461 454
Mean 1.07 1.05
SE 0.01 0.01


4 months

N Analyzed 452 439
Mean 1.07 1.07
SE 0.01 0.01


6 months

N Analyzed 441 425
Mean 1.09 1.08
SE 0.01 0.01
Outcome: lipid      Population: 51889
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) Placebo


0 months

N Analyzed
Mean
SD
SE


2 months

N Analyzed
Mean
SD
SE


4 months

N Analyzed
Mean
SD
SE


6 months

N Analyzed
Mean
SD
SE
Outcome: lipid      Population: 51889
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) Placebo


0 months

N Analyzed
Mean
SE


2 months

N Analyzed
Mean
SE


4 months

N Analyzed
Mean
SE


6 months

N Analyzed
Mean
SE
Outcome: lipid      Population: 51890
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) Placebo


0 months

N Analyzed 470 465
Mean 3.5 3.5
SE .05 .05


6 months

N Analyzed 441 425
Mean 3.73 3.56
SE .06 .05
Outcome: lipid      Population: 51891
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) Placebo


0 months

N Analyzed 470 465
Mean 3.32 3.36
SE 0.04 0.04


2 months

N Analyzed 462 453
Mean 2.74 3.18
SE 0.05 0.05


4 months

N Analyzed 451 439
Mean 2.74 3.19
SE 0.05 0.06


6 months

N Analyzed 440 426
Mean 2.67 3.13
SE 0.04 0.08

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
All n-3 PUFAs (ALA+DHA+EPA) Adverse Event 1 mainly mild gastrointestinal disturbances 21 18 6 months
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Placebo 25 21 6 months

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? Yes randomization block technique
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Was ALLOCATION adequately concealed (prior to assignment)? No Data
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Were PARTICIPANTS adequately BLINDED? Yes
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Were OUTCOME ASSESSORS adequately BLINDED? Yes
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Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data No
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Is there evidence of SELECTIVE OUTCOME REPORTING bias (Yes/No)? No
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INTENTION-TO-TREAT analysis? (Yes/No) Yes
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Group SIMILARITY AT BASELINE (**GENERAL**) Yes
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Was there incomplete COMPLIANCE with interventions across groups? No
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Group SIMILARITY AT BASELINE (**OMEGA-3**) Unsure
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Additional Bias: Bias due to problems not covered elsewhere in the table.
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If outcome assessor blinding risk of bias is different for different outcomes (eg, lipids vs. MI), choose HIGH risk of bias and describe in Notes
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If attrition risk of bias is different for different outcomes (eg, lipids vs. MI) or different time points (eg, 1 year vs. 5 years), choose HIGH risk of bias and describe in Notes
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Quality Rating
No quality rating data was found.