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Effect of Omega-3 Fatty Acids on Insulin Sensitivity in Chinese Type 2 Diabetic Patients

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: NCT01857167
Recruitment Status : Completed
First Posted : May 20, 2013
Last Update Posted : March 17, 2015
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Duo li, Zhejiang University

Brief Summary:
This study is to examine the change of fasting insulin, glucose, insulin sensitivity and related traits in response to the six month treatment of omega-3 fatty acids, including fish oil and flaxseed oil, in Chinese type 2 diabetic patients. Corn oil, rich in omega-6 fatty acids, will be selected as a controlled oil. The investigators hypothesize that omega-3 fatty acids could improve insulin sensitivity and glucose metabolism in Chinese type 2 diabetic patients.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Insulin Resistance Dietary Supplement: Fish Oil Supplementation Dietary Supplement: Flaxseed Oil Supplementation Dietary Supplement: placebo Not Applicable

Detailed Description:
The insulin resistance will be estimated by a homeostatic model assessment model of insulin resistance (HOMA-IR)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Study Start Date : June 2013
Actual Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fish Oil Supplementation
Patients will receive fish oil capsules, at a dose of 4g/day. Each 1g capsule will contain 300mg of EPA and 200mg of DHA.
Dietary Supplement: Fish Oil Supplementation
Experimental: Flaxseed Oil Supplementation
Patients will receive flaxseed oil capsule, at a dose of 4g/day. Each 1g capsule will contain 630mg of ALA
Dietary Supplement: Flaxseed Oil Supplementation
Placebo Comparator: Placebo Supplementation
Patients will receive corn oil in the capsules at the same dose as fish oil. The corn oil will appear identical in size and color to the fish oil.
Dietary Supplement: placebo



Primary Outcome Measures :
  1. insulin resistance [ Time Frame: 180 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Fasting glucose > 7.0 or have diabetes medication;
  2. Male, 35-80 years; female, postmenopausal to 80 years;
  3. Agree to participant in the trial.

Exclusion Criteria:

  1. Deny to sign the informed consent;
  2. type 1 diabetes;
  3. Family history of hypertriglyceridemia or fasting triglyceride>4.56 mmol/L;
  4. Have severe liver disease, kidney disease or cancer;
  5. Participating in the other clinical trial within 30 days;
  6. Other diseases or conditions, for which the doctor of the patients do not agree his or her participating.

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): NCT01857167


Locations
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China, Zhejiang
Zhejiang University
Hangzhou, Zhejiang, China, 310058
Sponsors and Collaborators
Zhejiang University
National Natural Science Foundation of China
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duo li, Professor, Zhejiang University
ClinicalTrials.gov Identifier: NCT01857167    
Other Study ID Numbers: DUOLI2013011
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015
Keywords provided by Duo li, Zhejiang University:
omega-3 fatty acids
randomized controlled trial
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases