Type 2 Diabetes MellitusPhase 4NCT03120299
The Effect of Omega-3 FA on Hypertriglyceridemia in Patients With T2DM(OCEAN)
A Phase 4 study testing Omega-3 fatty acid in people with Type 2 Diabetes Mellitus and Hypertriglyceridemia, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Hypertriglyceridemia
- What is being tested?
- Omega-3 fatty acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 309 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 1 Jun 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin hospital, Shanghai Jiao-Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: The Effect of Omega-3 Fatty Acids on Hypertriglyceridemia in Patients With Type 2 Diabetes Mellitus
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.
Read the 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
- Being tested
- Omega-3 fatty acid, Placebos
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acidDrug
Also called fish oil supplement
Omega-3 fatty acids capsules, 1 gram gel capsule, 2 capsules orally administered twice a day for 12 weeks
PlacebosDrug
Matching placebo capsules, 1 gram gel capsule, 2 capsules orally administered twice a day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum triglycerides from baseline
With aid of autoanalyser, the investigators will measure the serum triglycerides in blood samples before and after treatment.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (21)
Change in serum metabolomics profile of bile acids from baseline
With aid of LC/MS and GC/MS technique, the investigators will measure the blood metabolomics molecular profile of bile acids in blood samples before and after treatment.
Measured: 12 weeks
Change in serum metabolomics profile of amino acid species from baseline
With aid of LC/MS and GC/MS technique, the investigators will measure the blood metabolomics molecular profile of amino acid species before and after treatment.
Measured: 12 weeks
Change in Gut microbiome from baseline
With aid of quantitative real-time PCR technique, the investigators will measure gut microbiome in fecal samples before and after treatment.
Measured: 12 weeks
Change in fasting glucose levels from baseline
With aid of autoanalyser, the investigators will measure fasting glucose levels before and after treatment.
Measured: 12 weeks
Change in 2-hour postprandial glucose levels from baseline
With aid of autoanalyser, the investigators will measure the 2-hour postprandial glucose levels before and after treatment.
Measured: 12 weeks
Change in HbA1c from baseline
With aid of HPLC technique, the investigators will measure the HbA1c levels before and after treatment.
Measured: 12 weeks
Change in Non-HDL-C from baseline
With aid of autoanalyser, the investigators will measure the non-HDL-c levels before and after treatment.
Measured: 12 weeks
Change in serum total Cholesterol from baseline
With aid of autoanalyser, the investigators will measure serum total cholesterol levels before and after treatment.
Measured: 12 weeks
Change in serum VLDL-c from baseline
With aid of autoanalyser, the investigators will measure serum VLDL-c levels before and after treatment.
Measured: 12 weeks
Change in serum HDL-c from baseline
With aid of autoanalyser, the investigators will measure serum HDL-c levels before and after treatment.
Measured: 12 weeks
Change in serum LDL-c from baseline
With aid of autoanalyser, the investigators will measure serum LDL-c levels before and after treatment.
Measured: 12 weeks
Change in LDL-C/HDL-C from baseline
The LDL-C/HDL-C will be calculated by the ratio of the LDL-C divided by HDL-C before and after treatment.
Measured: 12 weeks
Change in serum Apo B from baseline
With aid of autoanalyser, the investigators will measure serum Apo B levels before and after treatment.
Measured: 12 weeks
Change in serum AST from baseline
With aid of autoanalyser, the investigators will measure serum AST levels before and after treatment.
Measured: 12 weeks
Change in serum ALT from baseline
In aid of autoanalyser, the investigators will measure serum ALT levels before and after treatment.
Measured: 12 weeks
Change in serum inflammation markers from baseline
With aid of autoanalyser, the investigators will measure hs-CRP, TNF-alfa, IL-6, and IL-8 etc before and after treatment.
Measured: 12 weeks
Change in liver fat content from baseline
With aid of ultrasonic diagnostic apparatus, the investigators will measure the fat content in liver before and after treatment.
Measured: 12 weeks
Change in Ankle-Brachial Index from baseline
The ABI value will be measured by PWV/ABI-form device (OMRON Colin Medical Instruments) before and after treatment.
Measured: 12 weeks
Change in Brachial-ankle pulse wave velocity from baseline
The baPWV value will be measured by PWV/ABI form device (OMRON Colin Medical Instruments) before and after treatment.
Measured: 12 weeks
Change in enrichment of fish oil in red blood cell from baseline
With aid of HPLC-ESI-MS/MS, the investigators will measure the enrichment of fish oil in red blood cell before and after treatment
Measured: 12 weeks
Pharmacogenomics analysis
With aid of blood DNA genotyping，the investigators will compare the genotype of FASD1,FASD2 and other lipid related candidate genes with the lipid lowering effect of omega-3
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start1 May 2017
- Primary completion1 Mar 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guang Ning, Shanghai Jiao Tong University School of Medicine
- Investigators
- Guang Ning, MD, PHD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120299
- Sponsor's protocol ID
- CCMED-20160601
- Status last verified
- Oct 2023
- First submitted
- 15 Apr 2017
- Last updated
- 30 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39163858
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Omega-3 Fatty Acids on Hypertriglyceridemia in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03120299
- Acronym / sponsor ID
- CCMED-20160601
- Conditions
- Type 2 Diabetes Mellitus, Hypertriglyceridemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 19 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A Drug | Experimental | Drug: Omega-3 fatty acidOmega-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 B Drug | Placebo comparator | Drug: PlacebosMatching placebo capsules, 1 gram gel capsule, 2 capsules orally administered twice a day for 12 weeks |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (15 listed)
- 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）
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 fatty acidAlso: fish oil supplementOmega-3 fatty acids capsules, 1 gram gel capsule, 2 capsules orally administered twice a day for 12 weeks | Drug | Group A Drug |
| PlacebosMatching placebo capsules, 1 gram gel capsule, 2 capsules orally administered twice a day for 12 weeks | Drug | Group B Drug |
Primary outcome
Change in serum triglycerides from baseline
Time frame: 12 weeks
With aid of autoanalyser, the investigators will measure the serum triglycerides in blood samples before and after treatment.
Change in blood metabolomics profile of lipid species from baseline
Time frame: 12 weeks
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.
21 secondary outcomes
Change in serum metabolomics profile of bile acids from baseline
Time frame: 12 weeks
Change in serum metabolomics profile of amino acid species from baseline
Time frame: 12 weeks
Change in Gut microbiome from baseline
Time frame: 12 weeks
Change in fasting glucose levels from baseline
Time frame: 12 weeks
Change in 2-hour postprandial glucose levels from baseline
Time frame: 12 weeks
Change in HbA1c from baseline
Time frame: 12 weeks
Change in Non-HDL-C from baseline
Time frame: 12 weeks
Change in serum total Cholesterol from baseline
Time frame: 12 weeks
Change in serum VLDL-c from baseline
Time frame: 12 weeks
Change in serum HDL-c from baseline
Time frame: 12 weeks
Change in serum LDL-c from baseline
Time frame: 12 weeks
Change in LDL-C/HDL-C from baseline
Time frame: 12 weeks
Change in serum Apo B from baseline
Time frame: 12 weeks
Change in serum AST from baseline
Time frame: 12 weeks
Change in serum ALT from baseline
Time frame: 12 weeks
Change in serum inflammation markers from baseline
Time frame: 12 weeks
Change in liver fat content from baseline
Time frame: 12 weeks
Change in Ankle-Brachial Index from baseline
Time frame: 12 weeks
Change in Brachial-ankle pulse wave velocity from baseline
Time frame: 12 weeks
Change in enrichment of fish oil in red blood cell from baseline
Time frame: 12 weeks
Pharmacogenomics analysis
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Derived from this study: PubMed 39163858Lu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guang Ning, MD, PHD principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omega-3 fatty acid in people with Type 2 Diabetes Mellitus and Hypertriglyceridemia, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum triglycerides from baseline (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03120299, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.