The Effect of Omega-3 FA on Hypertriglyceridemia in Patients With T2DM(OCEAN)

NCT ID: NCT03120299

Last Updated: 2023-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 309 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2021-06-01

Brief Summary

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.

Detailed Description

In the present study, patients with type 2 diabetes and hypertriglyceride will be enrolled from multiple centers in China. Randomization was computer generated and stratified by center. After screening, eligible subjects will be randomly assigned into one of the following two groups: Omega-3 fatty acids capsules ( 2pills bid) and placebo capsules (2pills bid).

Blood, feces and urine samples will be collected before and after treatment. Triglycerides (TG), total cholesterol (TC), LDL-C, HDL-C, HbA1C, fasting plasma glucose (FPG), postprandial plasma glucose (PPG) will be measured. Blood metabolomics profiles of lipids, amino acids, bile acids, the change of gut microbiota, and pharmacogenomic components and parameters will be evaluated too.

Sample Size Calculation:

The primary clinical endpoint involves comparing changes in triglyceride (TG) levels between the placebo group and the omega-3 treatment group after a 12-week intervention. According to literature reports [Borthwick L J. The effects of an omega-3 ethyl ester concentrate on blood lipid concentrations in patients with hyperlipidaemia[J]. Clinical drug investigation, 1998, 15(5): 397-404], following 12 weeks of n-3 or placebo-controlled treatment, patients with hypertriglyceridemia exhibited a 9.1±24.8% increase in the placebo group and a 28.3±19.1% decrease in the omega-3 treatment group (4g/day). Based on this data, we conservatively estimate no change in TG in the placebo group for this trial, while anticipating a 10% reduction in the omega-3 treatment group. With a combined standard deviation (SD) of 30%, α=0.05, β=0.2, we calculate the sample size based on the mean difference between the two groups, resulting in N1=N2=143 cases.

Taking into account actual follow-up rates from preliminary research, we adjusted the estimated dropout rate from 20% to 5% and recalculated the sample size. Consequently, we plan to enroll 300 cases, with 150 in each of the omega-3 treatment and placebo groups, respectively.

Conditions

Type 2 Diabetes Mellitus; Hypertriglyceridemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group A Drug

Omega-3 fatty acids capsules, 1 gram gel capsule, 2 capsules orally administered twice a day for 12 weeks

Other Names:

Omega-3 Fatty Acid fish oil Omega 3 Treasure

Group Type: EXPERIMENTAL

Omega-3 fatty acid

Intervention Type: DRUG

Omega-3 fatty acids capsules, 1 gram gel capsule, 2 capsules orally administered twice a day for 12 weeks

Group B Drug

Matching placebo capsules, 1 gram gel capsule, 2 capsules orally administered twice a day for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

Matching placebo capsules, 1 gram gel capsule, 2 capsules orally administered twice a day for 12 weeks

Interventions

Omega-3 fatty acid

Omega-3 fatty acids capsules, 1 gram gel capsule, 2 capsules orally administered twice a day for 12 weeks

Intervention Type: DRUG

Placebos

Matching placebo capsules, 1 gram gel capsule, 2 capsules orally administered twice a day for 12 weeks

Intervention Type: DRUG

Other Intervention Names

fish oil supplement

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Guang Ning

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guang Ning, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

Ruijin hospital, Shanghai Jiao-Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

References

Lu J, Liu R, Ren H, Wang S, Hu C, Shi Z, Li M, Liu W, Wan Q, Su Q, Li Q, Zheng H, Qu S, Yang F, Ji H, Lin H, Qi H, Wu X, Wu K, Chen Y, Xu Y, Xu M, Wang T, Zheng J, Ning G, Zheng R, Bi Y, Zhong H, Wang W. Impact of omega-3 fatty acids on hypertriglyceridemia, lipidomics, and gut microbiome in patients with type 2 diabetes. Med. 2025 Jan 10;6(1):100496. doi: 10.1016/j.medj.2024.07.024. Epub 2024 Aug 19.

Reference Type: DERIVED

PMID: 39163858 (View on PubMed)

Other Identifiers

CCMED-20160601

Identifier Type: -

Identifier Source: org_study_id