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

Not Applicable

• Conditions: Gestational Diabetes
• Interventions: Dietary Supplement: Fish oil; Dietary Supplement: Flaxseed oil

• Registration Number: NCT01912170
• 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 14 wk treatment of omega-3 fatty acids, including fish oil (n=25) and flaxseed oil(n=25), in Chinese gestational diabetic patients. Corn oil(n=25), rich in omega-6 fatty acids, will be selected as a controlled oil. The intervention will start from the third trimester of these pregnant women and finish at the 4wk after the birth of their children. The investigators hypothesize that omega-3 fatty acids could improve insulin sensitivity and glucose metabolism in these patients.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-07
• Study First Submitted: 2013-07-27
• Study First Submitted QC: 2013-07-27
• Last Update Submitted: 2013-07-27
• Study First Posted: 2013-07-30
• Last Update Posted: 2013-07-30
• Study Start: 2013-08
• Primary Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 75

Inclusion Criteria

• 1)gestational diabetes 2) female, <40 years old 3)willing to participant in the trial

Exclusion Criteria

• 1）type 1 diabetes or type 2 diabetes before pregnancy 2）Deny to sign the informed consent 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
fish oil	Fish oil	Patients will receive fish oil capsules, at a dose of 2g/day. Each 1g capsule will contain 220mg of EPA and 170mg of DHA
Flaxseed Oil	Flaxseed oil	Patients will receive flaxseed oil capsule, at a dose of 2g/day. Each 1g capsule will contain 550mg of ALA

Primary Outcome Measures

Name	Time	Method
fasting glucose	14 weeks
Fasting insulin	14 weeks

Secondary Outcome Measures

Name	Time	Method
birth weight, length of children	10 weeks

Trial Locations

Locations (1)

Jiaxing Women's and Children's Hospital; 🇨🇳 Jiaxing, Zhejiang, China