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

Zhejiang University

Status: Unknown

Conditions: Gestational Diabetes

Treatments: Dietary Supplement: Fish oil; Dietary Supplement: Flaxseed oil

Study type: Interventional

Funder types: Other

Identifiers

NCT01912170

DUOLI_GD

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 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.

Enrollment: 75 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 3 patient groups, including a placebo group

fish oil

Experimental group

Description:

Patients will receive fish oil capsules, at a dose of 2g/day. Each 1g capsule will contain 220mg of EPA and 170mg of DHA

Treatment:

Dietary Supplement: Fish oil

Flaxseed Oil

Experimental group

Description:

Patients will receive flaxseed oil capsule, at a dose of 2g/day. Each 1g capsule will contain 550mg of ALA

Treatment:

Dietary Supplement: Flaxseed oil

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