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

Zhejiang University

Status: Completed

Conditions: Insulin Resistance; Type 2 Diabetes

Treatments: Dietary Supplement: placebo; Dietary Supplement: Flaxseed Oil Supplementation; Dietary Supplement: Fish Oil Supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT01857167

DUOLI2013011

Details and patient eligibility

About

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.

Full description

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

Enrollment: 185 patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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185 participants in 3 patient groups, including a placebo group

Fish Oil Supplementation

Experimental group

Description:

Patients will receive fish oil capsules, at a dose of 4g/day. Each 1g capsule will contain 300mg of EPA and 200mg of DHA.

Treatment:

Dietary Supplement: Fish Oil Supplementation

Flaxseed Oil Supplementation

Experimental group

Description:

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

Treatment:

Dietary Supplement: Flaxseed Oil Supplementation

Placebo Supplementation

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: placebo