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

Gestational Diabetes Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01912170
• Other study ID #: DUOLI_GD
• Status: Not yet recruiting
• Phase: N/A
• First received: July 27, 2013
• Last updated: July 27, 2013
• Start date: August 2013

Study information

• Verified date: July 2013
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethics Committee of the College of Biosystem Engineering & Food Science, Zhejiang University: China
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

Dietary Supplement:
• Fish oil

• Flaxseed oil

Locations

Country	Name	City	State
China	Jiaxing Women's and Children's Hospital	Jiaxing	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Zhejiang University	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	blood lipids, inflammatory markers		14 weeks	No
Primary	fasting glucose		14 weeks	No
Primary	Fasting insulin		14 weeks	No
Secondary	birth weight, length of children		10 weeks	No