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

Study Overview
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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.

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: omega-3
* Dietary Supplement: placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: diabetes, omega-3<br>patient with type 2 diabetes who receive 4gr/day omega-3 | Dietary Supplement: omega-3<br>* 4 cap 1 gr omega-3 per day for 10 weeks<br>* Other names: n-3 fatty acids,n-3 PUFA;|
| Placebo Comparator: placebo, diabetes<br>patient with type 2 diabetes who receive 4 cap of placebo/day | Dietary Supplement: placebo<br>* patient with type 2 diabetes who receive 4 cap placebo/day for 10 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gene expression of C5L2 |  | change from baseline at 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASP, LCN2, RBP4, C5L2