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

NCT01912170 | Unknown

• 1 other identifier: DUOLI_GD
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes

Keywords

omega-3 fatty acid; gestational diabetes; insulin sensitivity

Outcome Measures

Primary Outcomes (2)

• fasting glucose

  14 weeks

• Fasting insulin

  14 weeks

Secondary Outcomes (1)

• birth weight, length of children

  10 weeks

Other Outcomes (1)

• blood lipids, inflammatory markers

  14 weeks

Study Arms (3)

fish oil

EXPERIMENTAL

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

Flaxseed Oil

EXPERIMENTAL

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 Supplementation

PLACEBO COMPARATOR

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

Fish oil DIETARY_SUPPLEMENT

fish oil

Flaxseed oil DIETARY_SUPPLEMENT

Flaxseed Oil

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• ）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

Sponsors & Collaborators

• Zhejiang University: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Jiaxing Women's and Children's Hospital

Jiaxing, Zhejiang, China

Location

MeSH Terms

Conditions

Diabetes, Gestational; Insulin Resistance

Interventions

Fish Oils; Linseed Oil

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Oils; Lipids; Fats, Unsaturated; Fats; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 27, 2013
• First Posted: July 30, 2013
• Study Start: August 1, 2013
• Primary Completion: February 1, 2014
• Last Updated: July 30, 2013

Record last verified: 2013-07

Locations

CN (1)