Ignite Creation Date:
2024-05-06 @ 3:21 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02261545
Status:
UNKNOWN
Last Update Posted:
2015-11-18
First Post:
2014-10-07
Brief Title:
The Effect of n-3 Fatty Acid Supplementation on Serum Levels and Gene Expression of type2 Diabetes Patient
Sponsor:
Tehran University of Medical Sciences
Organization:
Tehran University of Medical Sciences
Study Overview
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 ResistinMonocyte Chemotactic Protein MCP-1 and Adiponectin of type2 Diabetes Patient
Status:
UNKNOWN
Status Verified Date:
2015-11
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 AdipoR1adiponectin 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 EPAEicosapentaenoic acid 900mg DHA docosahexaenoic acid total2700mg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None