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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03120299
Recruitment Status : Unknown
Verified April 2017 by Guang Ning, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : April 19, 2017
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
Guang Ning, Shanghai Jiao Tong University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Hypertriglyceridemia Drug: Omega-3 fatty acid Drug: Placebos Phase 4

Detailed Description:

In the present study, about 350 type 2 diabetes patients with 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Omega-3 Fatty Acids on Hypertriglyceridemia in Patients With Type 2 Diabetes Mellitus
Estimated Study Start Date : May 1, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides

Arm Intervention/treatment
Experimental: 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

Drug: Omega-3 fatty acid
Omega-3 fatty acids capsules, 1 gram gel capsule, 2 capsules orally administered twice a day for 12 weeks
Other Name: fish oil supplement

Placebo Comparator: Group B Drug
Matching placebo capsules, 1 gram gel capsule, 2 capsules orally administered twice a day for 12 weeks
Drug: Placebos
Matching placebo capsules, 1 gram gel capsule, 2 capsules orally administered twice a day for 12 weeks




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Change in serum metabolomics profile of bile acids from baseline [ Time Frame: 12 weeks ]
    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.

  2. Change in serum metabolomics profile of amino acid species from baseline [ Time Frame: 12 weeks ]
    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.

  3. Change in serum Gut microbiome from baseline [ Time Frame: 12 weeks ]
    With aid of quantitative real-time PCR technique, the investigators will measure gut microbiome in fecal samples before and after treatment.

  4. Change in fasting glucose levels from baseline [ Time Frame: 12 weeks ]
    With aid of autoanalyser, the investigators will measure fasting glucose levels before and after treatment.

  5. Change in 2-hour postprandial glucose levels from baseline [ Time Frame: 12 weeks ]
    With aid of autoanalyser, the investigators will measure the 2-hour postprandial glucose levels before and after treatment.

  6. Change in HbA1c from baseline [ Time Frame: 12 weeks ]
    With aid of HPLC technique, the investigators will measure the HbA1c levels before and after treatment.

  7. Change in Non-HDL-C from baseline [ Time Frame: 12 weeks ]
    With aid of autoanalyser, the investigators will measure the non-HDL-c levels before and after treatment.

  8. Change in serum total Cholesterol from baseline [ Time Frame: 12 weeks ]
    With aid of autoanalyser, the investigators will measure serum total cholesterol levels before and after treatment.

  9. Change in serum VLDL-c from baseline [ Time Frame: 12 weeks ]
    With aid of autoanalyser, the investigators will measure serum VLDL-c levels before and after treatment.

  10. Change in serum HDL-c from baseline [ Time Frame: 12 weeks ]
    With aid of autoanalyser, the investigators will measure serum HDL-c levels before and after treatment.

  11. Change in serum LDL-c from baseline [ Time Frame: 12 weeks ]
    With aid of autoanalyser, the investigators will measure serum LDL-c levels before and after treatment.

  12. Change in LDL-C/HDL-C from baseline [ Time Frame: 12 weeks ]
    The LDL-C/HDL-C will be calculated by the ratio of the LDL-C divided by HDL-C before and after treatment.

  13. Change in serum Apo B from baseline [ Time Frame: 12 weeks ]
    With aid of autoanalyser, the investigators will measure serum Apo B levels before and after treatment.

  14. Change in serum AST from baseline [ Time Frame: 12 weeks ]
    With aid of autoanalyser, the investigators will measure serum AST levels before and after treatment.

  15. Change in serum ALT from baseline [ Time Frame: 12 weeks ]
    In aid of autoanalyser, the investigators will measure serum ALT levels before and after treatment.

  16. Change in serum inflammation markers from baseline [ Time Frame: 12 weeks ]
    With aid of autoanalyser, the investigators will measure hs-CRP, TNF-alfa, IL-6, and IL-8 etc before and after treatment.

  17. Change in liver fat content from baseline [ Time Frame: 12 weeks ]
    With aid of ultrasonic diagnostic apparatus, the investigators will measure the fat content in liver before and after treatment.

  18. Change in Ankle-Brachial Index from baseline [ Time Frame: 12 weeks ]
    The ABI value will be measured by PWV/ABI-form device (OMRON Colin Medical Instruments) before and after treatment.

  19. Change in Brachial-ankle pulse wave velocity from baseline [ Time Frame: 12 weeks ]
    The baPWV value will be measured by PWV/ABI form device (OMRON Colin Medical Instruments) before and after treatment.

  20. Change in enrichment of fish oil in red blood cell from baseline [ Time Frame: 12 weeks ]
    With aid of HPLC-ESI-MS/MS, the investigators will measure the enrichment of fish oil in red blood cell before and after treatment

  21. Pharmacogenomics analysis [ Time Frame: 12 weeks ]
    With aid of blood DNA genotyping,the investigators will compare the genotype of FASD1,FASD2 ect and the lipid lowering effect of omega-3



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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<60×109/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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03120299


Contacts
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Contact: Guang Ning, MD, PHD +8621-64370045 ext 671817 guangning@medmail.com.cn
Contact: Jieli Lu, MD, PHD +8621-64370045 ext 671817 jielilu@hotmail.com

Locations
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China, Shanghai
Ruijin hospital, Shanghai Jiao-Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Guang Ning, Professor    8621-64370045 ext 665344    feifei1116@hotmail.com   
Principal Investigator: Guang Ning, Professor         
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Guang Ning, MD, PHD Ruijin Hospital

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Responsible Party: Guang Ning, Professor, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03120299    
Other Study ID Numbers: CCMED-20160601
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertriglyceridemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders