Effect of Omega-3 Fatty Acids on Insulin Sensitivity in Chinese Type 2 Diabetic Patients
1 other identifier
interventional
185
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2013
CompletedFirst Posted
Study publicly available on registry
May 20, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedMarch 17, 2015
March 1, 2015
1.5 years
May 10, 2013
March 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
insulin resistance
180 days
Study Arms (3)
Fish Oil Supplementation
EXPERIMENTALPatients will receive fish oil capsules, at a dose of 4g/day. Each 1g capsule will contain 300mg of EPA and 200mg of DHA.
Flaxseed Oil Supplementation
EXPERIMENTALPatients will receive flaxseed oil capsule, at a dose of 4g/day. Each 1g capsule will contain 630mg of ALA
Placebo Supplementation
PLACEBO COMPARATORPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- Fasting glucose \> 7.0 or have diabetes medication;
- Male, 35-80 years; female, postmenopausal to 80 years;
- Agree to participant in the trial.
You may not qualify if:
- Deny to sign the informed consent;
- type 1 diabetes;
- Family history of hypertriglyceridemia or fasting triglyceride\>4.56 mmol/L;
- Have severe liver disease, kidney disease or cancer;
- Participating in the other clinical trial within 30 days;
- Other diseases or conditions, for which the doctor of the patients do not agree his or her participating.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhejiang Universitylead
- National Natural Science Foundation of Chinacollaborator
Study Sites (1)
Zhejiang University
Hangzhou, Zhejiang, 310058, China
Related Publications (2)
Zheng JS, Huang T, Yang J, Fu YQ, Li D. Marine N-3 polyunsaturated fatty acids are inversely associated with risk of type 2 diabetes in Asians: a systematic review and meta-analysis. PLoS One. 2012;7(9):e44525. doi: 10.1371/journal.pone.0044525. Epub 2012 Sep 11.
PMID: 22984522BACKGROUNDZheng JS, Lin M, Fang L, Yu Y, Yuan L, Jin Y, Feng J, Wang L, Yang H, Chen W, Li D, Tang J, Cai W, Shi M, Li Z, Wang F, Li D. Effects of n-3 fatty acid supplements on glycemic traits in Chinese type 2 diabetic patients: A double-blind randomized controlled trial. Mol Nutr Food Res. 2016 Oct;60(10):2176-2184. doi: 10.1002/mnfr.201600230. Epub 2016 Jul 12.
PMID: 27279274DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 10, 2013
First Posted
May 20, 2013
Study Start
June 1, 2013
Primary Completion
December 1, 2014
Last Updated
March 17, 2015
Record last verified: 2015-03