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

Zhejiang University logo

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

  • 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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems