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

Type 2 Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01857167
• Other study ID #: DUOLI2013011
• Status: Completed
• Phase: N/A
• First received: May 10, 2013
• Last updated: March 11, 2015
• Start date: June 2013

Study information

• Verified date: March 2015
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee of the College of Biosystem Engineering & Food Science, Zhejiang University
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Insulin Resistance
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Fish Oil Supplementation

• Flaxseed Oil Supplementation

• placebo

Locations

Country	Name	City	State
China	Zhejiang University	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Zhejiang University	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin resistance		180 days	No