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

Not Applicable

Completed

• Conditions: Insulin Resistance; Type 2 Diabetes
• Interventions: Dietary Supplement: Flaxseed Oil Supplementation; Dietary Supplement: placebo; Dietary Supplement: Fish Oil Supplementation

• Registration Number: NCT01857167
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2013-05-10
• Study First Submitted QC: 2013-05-15
• Study First Posted: 2013-05-20
• Study Start: 2013-06
• Primary Completion: 2014-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-11
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flaxseed Oil Supplementation	Flaxseed Oil Supplementation	Patients will receive flaxseed oil capsule, at a dose of 4g/day. Each 1g capsule will contain 630mg of ALA
Placebo Supplementation	placebo	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.
Fish Oil Supplementation	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.

Primary Outcome Measures

Name	Time	Method
insulin resistance	180 days

Trial Locations

Locations (1)

Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China