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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01857167
Enrollment
185
Registered
2013-05-20
Start date
2013-06-30
Completion date
Unknown
Last updated
2015-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Type 2 Diabetes

Keywords

omega-3 fatty acids, randomized controlled trial

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)

Interventions

DIETARY_SUPPLEMENTFish Oil Supplementation
DIETARY_SUPPLEMENTFlaxseed Oil Supplementation
DIETARY_SUPPLEMENTplacebo

Sponsors

National Natural Science Foundation of China
CollaboratorOTHER_GOV
Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
insulin resistance180 days

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026