Diabetes Mellitus Type II
Conditions
Keywords
n-3 fatty acid, Sirt-1, AdipoR1, AdipoR2, MCP-1, Adiponectin, Resistin, T2DM
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
Interventions
DIETARY_SUPPLEMENTn-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.
DIETARY_SUPPLEMENTPlacebo
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.
Sponsors
Tehran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum Fasting Blood Sugar(FBS) | Change from baseline at 10 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Serum HbA1C | 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 |
| Serum Insulin | Change from baseline at 10 weeks |
| Beck depression score | Change from baseline at 10 weeks |
Outcome results
None listed