The Effect of n-3 Fatty Acid Supplementation on Serum Levels, and Gene Expression of type2 Diabetes Patient
Primary Purpose
Diabetes Mellitus Type II
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
n-3 Fatty Acid
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Mellitus Type II focused on measuring n-3 fatty acid, Sirt-1, AdipoR1, AdipoR2, MCP-1, Adiponectin, Resistin, T2DM
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
n-3 Fatty Acid Supplemetation
Placebo
Arm Description
patients with Type II Diabetes who receive 3 cap omega3, 3 times a day, for 10 weeks.
patients with Type II Diabetes who receive 3 cap of placebo/ for 10 weeks.
Outcomes
Primary Outcome Measures
Serum Fasting Blood Sugar(FBS)
Secondary Outcome Measures
Serum Insulin
Serum HbA1C
Serum Resistin
Serum adiponectin
Serum mcp-1
Gene Expression of AdipoR1
Gene Expression of AdipoR2
Gene Expression of Sirt-1
Beck depression score
Serum cholesterol
Serum LDL cholesterol
Serum TG
Serum HDL cholesterol
Full Information
NCT ID
NCT02261545
First Posted
October 7, 2014
Last Updated
November 17, 2015
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02261545
Brief Title
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
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
February 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type II
Keywords
n-3 fatty acid, Sirt-1, AdipoR1, AdipoR2, MCP-1, Adiponectin, Resistin, T2DM
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
n-3 Fatty Acid Supplemetation
Arm Type
Active Comparator
Arm Description
patients with Type II Diabetes who receive 3 cap omega3, 3 times a day, for 10 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
patients with Type II Diabetes who receive 3 cap of placebo/ for 10 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
n-3 Fatty Acid
Other Intervention Name(s)
omega-3, n-3 PUFA
Intervention Description
n-3 Fatty Acid supplement, 3 × 1000 mg softgel daily (2700 mg EPA+DHA per day), 3 times a day, for 10 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Serum Fasting Blood Sugar(FBS)
Time Frame
Change from baseline at 10 weeks
Secondary Outcome Measure Information:
Title
Serum Insulin
Time Frame
Change from baseline at 10 weeks
Title
Serum HbA1C
Time Frame
Change from baseline at 10 weeks
Title
Serum Resistin
Time Frame
Change from baseline at 10 weeks
Title
Serum adiponectin
Time Frame
Change from baseline at 10 weeks
Title
Serum mcp-1
Time Frame
Change from baseline at 10 weeks
Title
Gene Expression of AdipoR1
Time Frame
Change from baseline at 10 weeks
Title
Gene Expression of AdipoR2
Time Frame
Change from baseline at 10 weeks
Title
Gene Expression of Sirt-1
Time Frame
Change from baseline at 10 weeks
Title
Beck depression score
Time Frame
Change from baseline at 10 weeks
Title
Serum cholesterol
Time Frame
Change from baseline at 10 weeks
Title
Serum LDL cholesterol
Time Frame
Change from baseline at 10 weeks
Title
Serum TG
Time Frame
Change from baseline at 10 weeks
Title
Serum HDL cholesterol
Time Frame
Change from baseline at 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
29900143
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.
Results Reference
derived
Learn more about this trial
The Effect of n-3 Fatty Acid Supplementation on Serum Levels, and Gene Expression of type2 Diabetes Patient
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