The Impact of Omega-3 Supplementation on Gene Expression in Type 2 Diabetics

November 30, 2012 updated by: Tehran University of Medical Sciences

The Impact of Omega-3 Supplementation on Acylation Stimulating Protein(ASP), Retinol-binding Protein 4 (RBP4) and Lipocalin-2 (LCN2) Gene Expression of ASP Receptor (C5L2) in WBC of Patient With Diabetes Type 2

The aim of this study is the comparison between the effects of supplementation with omega-3 or placebo for 10 weeks in type 2 diabetics

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Adipose tissue is recognized as an important endocrine organ in human. Not only it has function of storing unlimited energy but also its secretory roles is subject to intense research in recent years. Acylation stimulating protein(ASP), Retinol-binding protein 4 (RBP4) and lipocalin-2 (LCN2) are circulating adipokines elevated in diabetes. C5L2 is a G-protein-coupled receptor. activation of C5L2 by ASP, has been shown. Fatty acids may influence the expression of adipokines. Epidemiological studies showed that omega-3 reduce the development of insulin resistance and diabetes. Because fatty acids are the main component of adipose tissue, it is essential interest to clarify the biological effects of omega-3 on the expression of relevant adipokines.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • literate
  • Willingness to participation
  • Diabetic patients 30-65 years old
  • Body mass index in the range 18.5-40
  • Avoidance of dietary supplements
  • vitamins and herbal products at least 2 weeks before and throughout the intervention

Exclusion Criteria:

  • people who have used omega-3 supplements in last 3 months
  • Having chronic renal disease
  • hepatic disease
  • gastrointestinal disease
  • hematological disorders
  • hypothyroidism or hyperthyroidism
  • Treatment with Orlistat or sibutramine for weight loss
  • Pregnancy and lactation
  • Treatment with insulin or Thiazolidinediones

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: diabetes, omega-3
patient with type 2 diabetes who receive 4gr/day omega-3
Dietary supplement: omega-3
4 cap 1 gr omega-3 per day for 10 weeks
Other Names:
  • n-3 fatty acids,n-3 PUFA
Placebo Comparator: placebo, diabetes
patient with type 2 diabetes who receive 4 cap of placebo/day
Dietary supplement: placebo
patient with type 2 diabetes who receive 4 cap placebo/day for 10 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum total cholesterol
Time Frame: change from baseline at 10 weeks
change from baseline at 10 weeks
serum High-density lipoprotein (HDL) cholesterol
Time Frame: change from baseline at 10 weeks
change from baseline at 10 weeks
serum Low-density lipoprotein (LDL) cholesterol
Time Frame: change from baseline at 10 weeks
change from baseline at 10 weeks
serum triglycerides (TG) level
Time Frame: change from baseline at 10 weeks
change from baseline at 10 weeks
postprandial triglycerides
Time Frame: change from baseline at 10 weeks
change from baseline at 10 weeks
complete blood count(CBC)
Time Frame: change from baseline at 10 weeks
change from baseline at 10 weeks
fasting plasma glucose(FPG)
Time Frame: change from baseline at 10 weeks
change from baseline at 10 weeks
Glycated hemoglobin (Hb A1c)
Time Frame: change from baseline at 10 weeks
change from baseline at 10 weeks
acylation stimulating protein (ASP)
Time Frame: change from baseline at 10 weeks
change from baseline at 10 weeks
lipocalin-2 (LCN2)
Time Frame: change from baseline at 10 weeks
change from baseline at 10 weeks
Retinol-binding protein 4 (RBP4)
Time Frame: change from baseline at 10 weeks
change from baseline at 10 weeks
non-esterified fatty acids (NEFA)
Time Frame: change from baseline at 10 weeks
change from baseline at 10 weeks
insulin
Time Frame: change from baseline at 10 weeks
change from baseline at 10 weeks
postprandial ASP
Time Frame: chage from baseline at 10 weeks
chage from baseline at 10 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
gene expression of C5L2
Time Frame: change from baseline at 10 weeks
change from baseline at 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

November 21, 2011

First Submitted That Met QC Criteria

November 22, 2011

First Posted (Estimate)

November 23, 2011

Study Record Updates

Last Update Posted (Estimate)

December 3, 2012

Last Update Submitted That Met QC Criteria

November 30, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 15176

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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