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

NCT ID: NCT01912170

Last Updated: 2013-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Brief Summary

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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

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Conditions

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Gestational Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Fish oil

Intervention Type DIETARY_SUPPLEMENT

Flaxseed Oil

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

Group Type EXPERIMENTAL

Flaxseed oil

Intervention Type DIETARY_SUPPLEMENT

Placebo Supplementation

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

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Fish oil

Intervention Type DIETARY_SUPPLEMENT

Flaxseed oil

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Natural Science Foundation of China

OTHER_GOV

Sponsor Role collaborator

Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Duo li

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jiaxing Women's and Children's Hospital

Jiaxing, Zhejiang, China

Site Status

Countries

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China

Facility Contacts

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Huijuan Liu

Role: primary

Other Identifiers

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DUOLI_GD

Identifier Type: -

Identifier Source: org_study_id

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