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

NCT ID: NCT01478776

Last Updated: 2012-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-09-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Type 2 Diabetes

Keywords

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ASP LCN2 RBP4 C5L2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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diabetes, omega-3

patient with type 2 diabetes who receive 4gr/day omega-3

Group Type ACTIVE_COMPARATOR

omega-3

Intervention Type DIETARY_SUPPLEMENT

4 cap 1 gr omega-3 per day for 10 weeks

placebo, diabetes

patient with type 2 diabetes who receive 4 cap of placebo/day

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

patient with type 2 diabetes who receive 4 cap placebo/day for 10 weeks

Interventions

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omega-3

4 cap 1 gr omega-3 per day for 10 weeks

Intervention Type DIETARY_SUPPLEMENT

placebo

patient with type 2 diabetes who receive 4 cap placebo/day for 10 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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n-3 fatty acids,n-3 PUFA

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tehran University of Medical Sciences

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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15176

Identifier Type: -

Identifier Source: org_study_id