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

NCT ID: NCT01857167

Last Updated: 2015-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Brief Summary

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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.

Detailed Description

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

Conditions

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Type 2 Diabetes Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Fish Oil Supplementation

Intervention Type DIETARY_SUPPLEMENT

Flaxseed Oil Supplementation

Patients will receive flaxseed oil capsule, at a dose of 4g/day. Each 1g capsule will contain 630mg of ALA

Group Type EXPERIMENTAL

Flaxseed Oil Supplementation

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Fish Oil Supplementation

Intervention Type DIETARY_SUPPLEMENT

Flaxseed Oil Supplementation

Intervention Type DIETARY_SUPPLEMENT

placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Natural Science Foundation of China

OTHER_GOV

Sponsor Role collaborator

Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Duo li

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 22984522 (View on PubMed)

Zheng 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.

Reference Type DERIVED
PMID: 27279274 (View on PubMed)

Other Identifiers

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DUOLI2013011

Identifier Type: -

Identifier Source: org_study_id

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