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

Diabetes Mellitus Type II Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02261545
• Other study ID #: 25367
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: October 7, 2014
• Last updated: November 17, 2015
• Start date: September 2014
• Est. completion date: February 2016

Study information

• Verified date: November 2015
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 88
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus Type II
• Diabetes Mellitus, Type 2

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Fasting Blood Sugar(FBS)		Change from baseline at 10 weeks	No
Secondary	Serum Insulin		Change from baseline at 10 weeks	No
Secondary	Serum HbA1C		Change from baseline at 10 weeks	No
Secondary	Serum Resistin		Change from baseline at 10 weeks	No
Secondary	Serum adiponectin		Change from baseline at 10 weeks	No
Secondary	Serum mcp-1		Change from baseline at 10 weeks	No
Secondary	Gene Expression of AdipoR1		Change from baseline at 10 weeks	No
Secondary	Gene Expression of AdipoR2		Change from baseline at 10 weeks	No
Secondary	Gene Expression of Sirt-1		Change from baseline at 10 weeks	No
Secondary	Beck depression score		Change from baseline at 10 weeks	Yes
Secondary	Serum cholesterol		Change from baseline at 10 weeks	No
Secondary	Serum LDL cholesterol		Change from baseline at 10 weeks	No
Secondary	Serum TG		Change from baseline at 10 weeks	No
Secondary	Serum HDL cholesterol		Change from baseline at 10 weeks	No