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Completed

NCT Number: NCT01857167

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhejiang University

Hangzhou, Zhejiang, 310058, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fasting glucose > 7.0 or have diabetes medication;
  • Male, 35-80 years; female, postmenopausal to 80 years;
  • Agree to participant in the trial.

Exclusion criteria

  • 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.

Treatment and study plan

Fish oil supplementation

Dietary Supplement

Flaxseed Oil Supplementation

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. insulin resistance

    Time frame: 180 days

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Collaborators

  • National Natural Science Foundation of China

Registry information

Important dates

Study start
2013
Primary completion
2014
First posted
May 20, 2013
Registry last updated
Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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