The Effect of n-3 Fatty Acid Supplementation on Serum Levels, and Gene Expression of type2 Diabetes Patient

Study Overview
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Brief Summary
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The aim of this study is to determine the effects of supplementation with n-3 fatty acid or placebo for 10 weeks on the expression of Sirt-1, AdipoR1 & AdipoR2 genes in the peripheral blood mononuclear cell (PBMC) and circulatory levels of Resistin, MCP-1 and Adiponectin of type2 diabetes patient

Detailed Description
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The aim of this study is to determine of the effects of supplementation with n-3 fatty acid or placebo for 10 weeks on the expression of Sirt-1, AdipoR1(adiponectin receptor 1) & AdipoR2 (adiponectin receptor 2) genes in the peripheral blood mononuclear cell (PBMC) and circulatory levels of Resistin, MCP-1 (Monocyte Chemoattractant Protein-1) and Adiponectin of type2 diabetes patient. In this randomized, double-blind clinical trial, placebo-controlled, 88 men and women with type 2 diabetes are enrolled in the study from the Iranian Diabetes Association. After signing informed consent all individuals complete a general information form , 24-hour food recall for 3 days and beck depression questionnaire will be taken from the participants at the beginning and the end of the study. Selected samples are randomly classified into 2 blocks of groups receiving supplement and placebo. The supplement group, will receive mg 1800mg EPA(Eicosapentaenoic acid ) & 900mg DHA( docosahexaenoic acid) (total=2700mg) for 10 weeks and the placebo group will also receive placebo (containing 2700 mg of edible paraffin) (similar in terms of color, shape and size). Patients are recommended to sustain their diets and medication dose (s) during the study and also advised to maintain a constant level of physical activity. Blood samples will be collected after 12 hours fasting and anthropometric variables, biochemical parameters, target gene expression and physical activity before and after the trial will be measured

Official Title
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The Effect of n-3 Fatty Acid Supplementation on the Expression of Sirt-1, Adiponectin Receptor 1 (AdipoR1) & Adiponectin Receptor 2 (AdipoR2) Genes of PBMC and Circulatory Levels of Resistin,Monocyte Chemotactic Protein (MCP-1) and Adiponectin of type2 Diabetes Patient

Conditions
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Diabetes Mellitus Type II

Intervention / Treatment
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* Dietary Supplement: n-3 Fatty Acid
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: willingness to participation, diabetic patients 30- 60 years old, body mass index in the range 25-40, avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention Exclusion Criteria: people who have used n-3 Fatty Acid Supplementation in last 3 months, having chronic renal disease , GI disease, Hepatobiliary diseases, hematological disorders, hypo- or hyperthyroidism, type 1 diabetes, 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: n-3 Fatty Acid Supplemetation<br>patients with Type II Diabetes who receive 3 cap omega3, 3 times a day, for 10 weeks. | Dietary Supplement: n-3 Fatty Acid<br>* n-3 Fatty Acid supplement, 3 × 1000 mg softgel daily (2700 mg EPA+DHA per day), 3 times a day, for 10 weeks.<br>* Other names: n-3 PUFA;|
| Placebo Comparator: Placebo<br>patients with Type II Diabetes who receive 3 cap of placebo/ for 10 weeks. | Dietary Supplement: Placebo<br>* 3 cap 1 g Placebo(paraffin) per day for 10 weeks. Control Group: n-3 Fatty Acid placebo softgel (Containing 3 g edible paraffin oil), 3 × 1000 mg softgel daily (3 g per day), 3 times a day, for 10 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Fasting Blood Sugar(FBS) |  | Change from baseline at 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Insulin |  | Change from baseline at 10 weeks | 
| Serum HbA1C |  | Change from baseline at 10 weeks | 
| Serum Resistin |  | Change from baseline at 10 weeks | 
| Serum adiponectin |  | Change from baseline at 10 weeks | 
| Serum mcp-1 |  | Change from baseline at 10 weeks | 
| Gene Expression of AdipoR1 |  | Change from baseline at 10 weeks | 
| Gene Expression of AdipoR2 |  | Change from baseline at 10 weeks | 
| Gene Expression of Sirt-1 |  | Change from baseline at 10 weeks | 
| Beck depression score |  | Change from baseline at 10 weeks | 
| Serum cholesterol |  | Change from baseline at 10 weeks | 
| Serum LDL cholesterol |  | Change from baseline at 10 weeks | 
| Serum TG |  | Change from baseline at 10 weeks | 
| Serum HDL cholesterol |  | 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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n-3 fatty acid, Sirt-1, AdipoR1, AdipoR2, MCP-1, Adiponectin, Resistin, T2DM