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

Primary Purpose

Gestational Diabetes

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Fish oil

Flaxseed oil

About this trial

This is an interventional treatment trial for Gestational Diabetes focused on measuring omega-3 fatty acid, gestational diabetes, insulin sensitivity

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Jiaxing Women's and Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

fish oil

Flaxseed Oil

Placebo Supplementation

Arm Description

Patients will receive fish oil capsules, at a dose of 2g/day. Each 1g capsule will contain 220mg of EPA and 170mg of DHA

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

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

Outcomes

Primary Outcome Measures

fasting glucose

Fasting insulin

Secondary Outcome Measures

birth weight, length of children

Full Information

NCT ID

NCT01912170

First Posted

July 27, 2013

Last Updated

July 27, 2013

Sponsor

Zhejiang University

Collaborators

National Natural Science Foundation of China

1. Study Identification

Unique Protocol Identification Number

NCT01912170

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Unknown status

Study Start Date

August 2013 (undefined)

Primary Completion Date

February 2014 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhejiang University

Collaborators

National Natural Science Foundation of China

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gestational Diabetes

Keywords

omega-3 fatty acid, gestational diabetes, insulin sensitivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

fish oil

Arm Type

Experimental

Arm Description

Patients will receive fish oil capsules, at a dose of 2g/day. Each 1g capsule will contain 220mg of EPA and 170mg of DHA

Arm Title

Flaxseed Oil

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo Supplementation

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Fish oil

Intervention Type

Dietary Supplement

Intervention Name(s)

Flaxseed oil

Primary Outcome Measure Information:

Title

fasting glucose

Time Frame

14 weeks

Title

Fasting insulin

Time Frame

14 weeks

Secondary Outcome Measure Information:

Title

birth weight, length of children

Time Frame

10 weeks

Other Pre-specified Outcome Measures:

Title

blood lipids, inflammatory markers

Time Frame

14 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Jiaxing Women's and Children's Hospital

City

Jiaxing

State/Province

Zhejiang

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Huijuan Liu

First Name & Middle Initial & Last Name & Degree

Duo Li, Ph.D.

12. IPD Sharing Statement

Learn more about this trial

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

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