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

July 27, 2013 updated by: Duo li, Zhejiang University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Jiaxing, Zhejiang, China
        • Jiaxing Women's and Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Dietary supplement: Fish oil
EXPERIMENTAL: Flaxseed Oil
Patients will receive flaxseed oil capsule, at a dose of 2g/day. Each 1g capsule will contain 550mg of ALA
Dietary supplement: Flaxseed oil
PLACEBO_COMPARATOR: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fasting glucose
Time Frame: 14 weeks
14 weeks
Fasting insulin
Time Frame: 14 weeks
14 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
birth weight, length of children
Time Frame: 10 weeks
10 weeks

Other Outcome Measures

Outcome Measure
Time Frame
blood lipids, inflammatory markers
Time Frame: 14 weeks
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Collaborators

National Natural Science Foundation of China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ANTICIPATED)

February 1, 2014

Study Registration Dates

First Submitted

July 27, 2013

First Submitted That Met QC Criteria

July 27, 2013

First Posted (ESTIMATE)

July 30, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

July 30, 2013

Last Update Submitted That Met QC Criteria

July 27, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DUOLI_GD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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