The Effect of Omega-3 Fatty Acids on Hypertriglyceridemia in Patients With Type 2 Diabetes Mellitus

CCMED-20160601

The purpose of this study is to conduct a multicenter randomized, double-blind, placebo-controlled clinical trial, evaluating the effects and change of lipid metabolism, especially of triglyceride after omega-3 administration in type 2 diabetes patients with hypertriglyceride.

2017-05-01

2021-03-01

2021-06-01

Completed

Early phase I

309

Inclusion Criteria: 1. Diagnosed type 2 diabetes defined as WHO (1999) diagnostic criteria ; Both Genders Eligible; 2. Men or women aged 20 to 75 years; 3. Stable dosage of oral anti-diabetic medicine ,stable glycemia control(HbA1c\<7.5%), unchanged antidiabetic therapy during the trial; 4. Hypertriglycerides (3.4mmol/L≤mean fasting blood triglycerides\<22.60mmol/L, and not receiving any lipid lowering therapy for 3 days continuously or accumulated 7 days within 6 weeks before screening). Exclusion Criteria: 1. Uncontrolled blood pressure (defined as systolic blood pressure\>180mmHg or diastolic blood pressure\>100mmHg); 2. Other diseases affecting lipid and glucose metabolism: hyperthyroidism，cushing syndrome ect; 3. Receiving insulin treatment in 6 months before recruitment; 4. Diagnosed heart failure, defined as New York Heart Association class III or IV; 5. Histories of acute or chronic pancreatitis，or cholelithiasis （except those received cholecystectomy） 6. Significant impaired liver function (defined as alanine transaminase (ALT)\> 3 times upper limit of normal), or active liver disease; 7. PLT\<60×10\^9/L，Hb\<100g/L； 8. Impaired renal function (defined as serum creatinine\> 135 mmol/L（1.5 mg/dL, male) and \> 110 mmol/L （1.3 mg/dL,female）； 9. Recorded history of malignant tumor in the past 2 years; 10. Histories of acute cerebrovascular accident within 6 months; 11. Pregnancy; 12. Known history of allergy to fish, shellfish and omega-3 fatty acids, or ineffective treatment of omega-3 fatty acids; 13. Simultaneous participation in any other clinical trial of an active pharmacologic agent within 30 days; 14. Other situations that interfere with the subject's ability to comply with study instructions; 15. Any other condition that investigators believe would interfere with the subject's ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at undue risk.

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2023-10-30