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Effect of Omega-3 Fatty Acids on Insulin Sensitivity in Chinese Type 2 Diabetic Patients

Primary Purpose

Type 2 Diabetes, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Fish Oil Supplementation
Flaxseed Oil Supplementation
placebo
Sponsored by
Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes focused on measuring omega-3 fatty acids, randomized controlled trial

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Fasting glucose > 7.0 or have diabetes medication;
  2. Male, 35-80 years; female, postmenopausal to 80 years;
  3. Agree to participant in the trial.

Exclusion Criteria:

  1. Deny to sign the informed consent;
  2. type 1 diabetes;
  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

  • Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Fish Oil Supplementation

Flaxseed Oil Supplementation

Placebo Supplementation

Arm Description

Patients will receive fish oil capsules, at a dose of 4g/day. Each 1g capsule will contain 300mg of EPA and 200mg of DHA.

Patients will receive flaxseed oil capsule, at a dose of 4g/day. Each 1g capsule will contain 630mg 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

insulin resistance

Secondary Outcome Measures

Full Information

First Posted
May 10, 2013
Last Updated
March 11, 2015
Sponsor
Zhejiang University
Collaborators
National Natural Science Foundation of China
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1. Study Identification

Unique Protocol Identification Number
NCT01857167
Brief Title
Effect of Omega-3 Fatty Acids on Insulin Sensitivity in Chinese Type 2 Diabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
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 six month treatment of omega-3 fatty acids, including fish oil and flaxseed oil, in Chinese type 2 diabetic patients. Corn oil, rich in omega-6 fatty acids, will be selected as a controlled oil. The investigators hypothesize that omega-3 fatty acids could improve insulin sensitivity and glucose metabolism in Chinese type 2 diabetic patients.
Detailed Description
The insulin resistance will be estimated by a homeostatic model assessment model of insulin resistance (HOMA-IR)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Insulin Resistance
Keywords
omega-3 fatty acids, randomized controlled trial

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
185 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fish Oil Supplementation
Arm Type
Experimental
Arm Description
Patients will receive fish oil capsules, at a dose of 4g/day. Each 1g capsule will contain 300mg of EPA and 200mg of DHA.
Arm Title
Flaxseed Oil Supplementation
Arm Type
Experimental
Arm Description
Patients will receive flaxseed oil capsule, at a dose of 4g/day. Each 1g capsule will contain 630mg 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 Supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
Flaxseed Oil Supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
insulin resistance
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fasting glucose > 7.0 or have diabetes medication; Male, 35-80 years; female, postmenopausal to 80 years; Agree to participant in the trial. Exclusion Criteria: Deny to sign the informed consent; type 1 diabetes; Family history of hypertriglyceridemia or fasting triglyceride>4.56 mmol/L; Have severe liver disease, kidney disease or cancer; Participating in the other clinical trial within 30 days; Other diseases or conditions, for which the doctor of the patients do not agree his or her participating.
Facility Information:
Facility Name
Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310058
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
22984522
Citation
Zheng JS, Huang T, Yang J, Fu YQ, Li D. Marine N-3 polyunsaturated fatty acids are inversely associated with risk of type 2 diabetes in Asians: a systematic review and meta-analysis. PLoS One. 2012;7(9):e44525. doi: 10.1371/journal.pone.0044525. Epub 2012 Sep 11.
Results Reference
background
PubMed Identifier
27279274
Citation
Zheng JS, Lin M, Fang L, Yu Y, Yuan L, Jin Y, Feng J, Wang L, Yang H, Chen W, Li D, Tang J, Cai W, Shi M, Li Z, Wang F, Li D. Effects of n-3 fatty acid supplements on glycemic traits in Chinese type 2 diabetic patients: A double-blind randomized controlled trial. Mol Nutr Food Res. 2016 Oct;60(10):2176-2184. doi: 10.1002/mnfr.201600230. Epub 2016 Jul 12.
Results Reference
derived

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Effect of Omega-3 Fatty Acids on Insulin Sensitivity in Chinese Type 2 Diabetic Patients

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