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Status unknownNCT01912170Updated Jul 30, 2013

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

An interventional study of Fish oil and Flaxseed oil in Gestational Diabetes, sponsored by Zhejiang University. Status unknown at 1 site in China. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2013-07-30.

Sponsored by Zhejiang University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2013), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Gestational Diabetes

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Keywords

  • omega-3 fatty acid
  • gestational diabetes
  • insulin sensitivity
03

In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.

This study's planned enrollment of 75 is below the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

Zhejiang University is the lead sponsor of 351 studies on the registry; 165 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
75 participants (estimated)

Study arms

  • 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

Interventions

  • Dietary supplementFish oil
  • Dietary supplementFlaxseed oil
06

What researchers measure

Primary outcomes

  1. fasting glucose

    Time frame: 14 weeks

  2. Fasting insulin

    Time frame: 14 weeks

Secondary outcomes

  1. birth weight, length of children

    Time frame: 10 weeks

Other outcomes

  1. blood lipids, inflammatory markers

    Time frame: 14 weeks

07

Study locations

1 site
  • Jiaxing Women's and Children's Hospital
    Jiaxing, Zhejiang, China
    • Huijuan Liu · Contact
    • Duo Li, Ph.D. · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01912170
Lead sponsor
Zhejiang University
Collaborators
National Natural Science Foundation of China
Responsible party
Duo li (Professor, Zhejiang University) — Principal investigator
First posted
Jul 30, 2013
Start date
Aug 2013
Primary completion
Feb 2014 (estimated)
Last update
Jul 30, 2013
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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