Clinical trial NCT02261545: The Effect of n-3 Fatty Acid Supplementation on Serum Levels, and Gene Expression of type2 Diabetes Patient
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus Type II
Keywords: n-3 fatty acid
Sirt-1
AdipoR1
AdipoR2
MCP-1
Adiponectin
Resistin
T2DM
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-10-10
Enrollment: 88
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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

Eligibility 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.

Primary outcomes:
measure: Serum Fasting Blood Sugar(FBS)
timeFrame: Change from baseline at 10 weeks
Secondary outcomes:
measure: Serum Insulin
timeFrame: Change from baseline at 10 weeks
measure: Serum HbA1C
timeFrame: Change from baseline at 10 weeks
measure: Serum Resistin
timeFrame: Change from baseline at 10 weeks
measure: Serum adiponectin
timeFrame: Change from baseline at 10 weeks
measure: Serum mcp-1
timeFrame: Change from baseline at 10 weeks
measure: Gene Expression of AdipoR1
timeFrame: Change from baseline at 10 weeks
measure: Gene Expression of AdipoR2
timeFrame: Change from baseline at 10 weeks
measure: Gene Expression of Sirt-1
timeFrame: Change from baseline at 10 weeks
measure: Beck depression score
timeFrame: Change from baseline at 10 weeks
measure: Serum cholesterol
timeFrame: Change from baseline at 10 weeks
measure: Serum LDL cholesterol
timeFrame: Change from baseline at 10 weeks
measure: Serum TG
timeFrame: Change from baseline at 10 weeks
measure: Serum HDL cholesterol
timeFrame: Change from baseline at 10 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Mazaherioun M, Saedisomeolia A, Javanbakht MH, Koohdani F, Zarei M, Ansari S, Khoshkhoo Bazargani F, Djalali M. Long Chain n-3 Fatty Acids Improve Depression Syndrome in Type 2 Diabetes Mellitus. Iran J Public Health. 2018 Apr;47(4):575-583.