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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01912170
Enrollment
75
Registered
2013-07-30
Start date
2013-08-31
Completion date
Unknown
Last updated
2013-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes

Keywords

omega-3 fatty acid, gestational diabetes, insulin sensitivity

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.

Interventions

DIETARY_SUPPLEMENTFish oil
DIETARY_SUPPLEMENTFlaxseed oil

Sponsors

National Natural Science Foundation of China
CollaboratorOTHER_GOV
Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
fasting glucose14 weeks
Fasting insulin14 weeks

Secondary

MeasureTime frame
birth weight, length of children10 weeks

Other

MeasureTime frame
blood lipids, inflammatory markers14 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026