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

November 17, 2015 updated by: Tehran University of Medical Sciences

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

88

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: n-3 Fatty Acid Supplemetation
patients with Type II Diabetes who receive 3 cap omega3, 3 times a day, for 10 weeks.
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.
Other Names:
  • n-3 PUFA
  • omega-3
Placebo Comparator: Placebo
patients with Type II Diabetes who receive 3 cap of placebo/ for 10 weeks.
Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum Fasting Blood Sugar(FBS)
Time Frame: Change from baseline at 10 weeks
Change from baseline at 10 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum Insulin
Time Frame: Change from baseline at 10 weeks
Change from baseline at 10 weeks
Serum HbA1C
Time Frame: Change from baseline at 10 weeks
Change from baseline at 10 weeks
Serum Resistin
Time Frame: Change from baseline at 10 weeks
Change from baseline at 10 weeks
Serum adiponectin
Time Frame: Change from baseline at 10 weeks
Change from baseline at 10 weeks
Serum mcp-1
Time Frame: Change from baseline at 10 weeks
Change from baseline at 10 weeks
Gene Expression of AdipoR1
Time Frame: Change from baseline at 10 weeks
Change from baseline at 10 weeks
Gene Expression of AdipoR2
Time Frame: Change from baseline at 10 weeks
Change from baseline at 10 weeks
Gene Expression of Sirt-1
Time Frame: Change from baseline at 10 weeks
Change from baseline at 10 weeks
Beck depression score
Time Frame: Change from baseline at 10 weeks
Change from baseline at 10 weeks
Serum cholesterol
Time Frame: Change from baseline at 10 weeks
Change from baseline at 10 weeks
Serum LDL cholesterol
Time Frame: Change from baseline at 10 weeks
Change from baseline at 10 weeks
Serum TG
Time Frame: Change from baseline at 10 weeks
Change from baseline at 10 weeks
Serum HDL cholesterol
Time Frame: Change from baseline at 10 weeks
Change from baseline at 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

October 7, 2014

First Submitted That Met QC Criteria

October 9, 2014

First Posted (Estimate)

October 10, 2014

Study Record Updates

Last Update Posted (Estimate)

November 18, 2015

Last Update Submitted That Met QC Criteria

November 17, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25367

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus Type II

Clinical Trials on n-3 Fatty Acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe