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

NCT03120299 | Completed Phase 4

• 1 other identifier: CCMED-20160601
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus; Hypertriglyceridemia

Outcome Measures

Primary Outcomes (2)

• Change in serum triglycerides from baseline

  With aid of autoanalyser, the investigators will measure the serum triglycerides in blood samples before and after treatment.

  12 weeks

• Change in blood metabolomics profile of lipid species from baseline

  With aid of LC/MS and GC/MS, the investigators will measure blood metabolomics profile of lipid species before and after treatment. The metabolomics measurement will help to detect the profile of all kinds of lipids species. The composition change of all these biological molecular induced by the treatment is our major interest rather than single molecular quantification.

  12 weeks

Secondary Outcomes (21)

• Change in serum metabolomics profile of bile acids from baseline

  12 weeks

• Change in serum metabolomics profile of amino acid species from baseline

  12 weeks

• Change in Gut microbiome from baseline

  12 weeks

• Change in fasting glucose levels from baseline

  12 weeks

• Change in 2-hour postprandial glucose levels from baseline

  12 weeks

Study Arms (2)

Group A Drug

EXPERIMENTAL

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

Drug: Omega-3 fatty acid

Group B Drug

PLACEBO COMPARATOR

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

Drug: Placebos

Interventions

Omega-3 fatty acid DRUG

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

Also known as: fish oil supplement

Group A Drug

Placebos DRUG

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

Group B Drug

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed type 2 diabetes defined as WHO (1999) diagnostic criteria ; Both Genders Eligible;
• Men or women aged 20 to 75 years;
• Stable dosage of oral anti-diabetic medicine ,stable glycemia control(HbA1c\<7.5%), unchanged antidiabetic therapy during the trial;
• 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).

You may not qualify if:

• Uncontrolled blood pressure (defined as systolic blood pressure\>180mmHg or diastolic blood pressure\>100mmHg);
• Other diseases affecting lipid and glucose metabolism: hyperthyroidism，cushing syndrome ect;
• Receiving insulin treatment in 6 months before recruitment;
• Diagnosed heart failure, defined as New York Heart Association class III or IV;
• Histories of acute or chronic pancreatitis，or cholelithiasis （except those received cholecystectomy）
• Significant impaired liver function (defined as alanine transaminase (ALT)\> 3 times upper limit of normal), or active liver disease;
• PLT\<60×10\^9/L，Hb\<100g/L；
• Impaired renal function (defined as serum creatinine\> 135 mmol/L（1.5 mg/dL, male) and \> 110 mmol/L （1.3 mg/dL,female）；
• Recorded history of malignant tumor in the past 2 years;
• Histories of acute cerebrovascular accident within 6 months;
• Pregnancy;
• Known history of allergy to fish, shellfish and omega-3 fatty acids, or ineffective treatment of omega-3 fatty acids;
• Simultaneous participation in any other clinical trial of an active pharmacologic agent within 30 days;
• Other situations that interfere with the subject's ability to comply with study instructions;
• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ruijin hospital, Shanghai Jiao-Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (1)

• 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.

  PMID: 39163858 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertriglyceridemia

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Guang Ning, MD, PHD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 15, 2017
• First Posted: April 19, 2017
• Study Start: May 1, 2017
• Primary Completion: March 1, 2021
• Study Completion: June 1, 2021
• Last Updated: October 30, 2023

Record last verified: 2023-10

Locations

CN (1)