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

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ClinicalTrials.gov Identifier: NCT02261545
Recruitment Status : Unknown
Verified November 2015 by Tehran University of Medical Sciences.
Recruitment status was:  Enrolling by invitation
First Posted : October 10, 2014
Last Update Posted : November 18, 2015
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type II Dietary Supplement: n-3 Fatty Acid Dietary Supplement: Placebo Phase 4

Detailed Description:
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: 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
Study Start Date : September 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: n-3 Fatty Acid Supplemetation
patients with Type II Diabetes who receive 3 cap omega3, 3 times a day, for 10 weeks.
Dietary Supplement: n-3 Fatty Acid
n-3 Fatty Acid supplement, 3 × 1000 mg softgel daily (2700 mg EPA+DHA per day), 3 times a day, for 10 weeks.
Other Names:
  • omega-3
  • n-3 PUFA

Placebo Comparator: Placebo
patients with Type II Diabetes who receive 3 cap of placebo/ for 10 weeks.
Dietary Supplement: Placebo
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.




Primary Outcome Measures :
  1. Serum Fasting Blood Sugar(FBS) [ Time Frame: Change from baseline at 10 weeks ]

Secondary Outcome Measures :
  1. Serum Insulin [ Time Frame: Change from baseline at 10 weeks ]
  2. Serum HbA1C [ Time Frame: Change from baseline at 10 weeks ]
  3. Serum Resistin [ Time Frame: Change from baseline at 10 weeks ]
  4. Serum adiponectin [ Time Frame: Change from baseline at 10 weeks ]
  5. Serum mcp-1 [ Time Frame: Change from baseline at 10 weeks ]
  6. Gene Expression of AdipoR1 [ Time Frame: Change from baseline at 10 weeks ]
  7. Gene Expression of AdipoR2 [ Time Frame: Change from baseline at 10 weeks ]
  8. Gene Expression of Sirt-1 [ Time Frame: Change from baseline at 10 weeks ]
  9. Beck depression score [ Time Frame: Change from baseline at 10 weeks ]
  10. Serum cholesterol [ Time Frame: Change from baseline at 10 weeks ]
  11. Serum LDL cholesterol [ Time Frame: Change from baseline at 10 weeks ]
  12. Serum TG [ Time Frame: Change from baseline at 10 weeks ]
  13. Serum HDL cholesterol [ Time Frame: Change from baseline at 10 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02261545    
Other Study ID Numbers: 25367
First Posted: October 10, 2014    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: November 2015
Keywords provided by Tehran University of Medical Sciences:
n-3 fatty acid
Sirt-1
AdipoR1
AdipoR2
MCP-1
Adiponectin
Resistin
T2DM
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases