The Impact of Omega-3 Supplementation on Gene Expression in Type 2 Diabetics

The Impact of Omega-3 Supplementation on Acylation Stimulating Protein(ASP), Retinol-binding Protein 4 (RBP4) and Lipocalin-2 (LCN2) Gene Expression of ASP Receptor (C5L2) in WBC of Patient With Diabetes Type 2

The aim of this study is the comparison between the effects of supplementation with omega-3 or placebo for 10 weeks in type 2 diabetics

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: omega-3; Dietary supplement: placebo

Detailed Description

Adipose tissue is recognized as an important endocrine organ in human. Not only it has function of storing unlimited energy but also its secretory roles is subject to intense research in recent years. Acylation stimulating protein(ASP), Retinol-binding protein 4 (RBP4) and lipocalin-2 (LCN2) are circulating adipokines elevated in diabetes. C5L2 is a G-protein-coupled receptor. activation of C5L2 by ASP, has been shown. Fatty acids may influence the expression of adipokines. Epidemiological studies showed that omega-3 reduce the development of insulin resistance and diabetes. Because fatty acids are the main component of adipose tissue, it is essential interest to clarify the biological effects of omega-3 on the expression of relevant adipokines.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Tehran University of Medical Sciences

Participation Criteria

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:

• literate
• Willingness to participation
• Diabetic patients 30-65 years old
• Body mass index in the range 18.5-40
• Avoidance of dietary supplements
• vitamins and herbal products at least 2 weeks before and throughout the intervention

Exclusion Criteria:

• people who have used omega-3 supplements in last 3 months
• Having chronic renal disease
• hepatic disease
• gastrointestinal disease
• hematological disorders
• hypothyroidism or hyperthyroidism
• Treatment with Orlistat or sibutramine for weight loss
• Pregnancy and lactation
• Treatment with insulin or Thiazolidinediones

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: diabetes, omega-3; patient with type 2 diabetes who receive 4gr/day omega-3	Dietary supplement: omega-3; 4 cap 1 gr omega-3 per day for 10 weeks; Other Names: n-3 fatty acids,n-3 PUFA
Placebo Comparator: placebo, diabetes; patient with type 2 diabetes who receive 4 cap of placebo/day	Dietary supplement: placebo; patient with type 2 diabetes who receive 4 cap placebo/day for 10 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
serum total cholesterol	change from baseline at 10 weeks
serum High-density lipoprotein (HDL) cholesterol	change from baseline at 10 weeks
serum Low-density lipoprotein (LDL) cholesterol	change from baseline at 10 weeks
serum triglycerides (TG) level	change from baseline at 10 weeks
postprandial triglycerides	change from baseline at 10 weeks
complete blood count(CBC)	change from baseline at 10 weeks
fasting plasma glucose(FPG)	change from baseline at 10 weeks
Glycated hemoglobin (Hb A1c)	change from baseline at 10 weeks
acylation stimulating protein (ASP)	change from baseline at 10 weeks
lipocalin-2 (LCN2)	change from baseline at 10 weeks
Retinol-binding protein 4 (RBP4)	change from baseline at 10 weeks
non-esterified fatty acids (NEFA)	change from baseline at 10 weeks
insulin	change from baseline at 10 weeks
postprandial ASP	chage from baseline at 10 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
gene expression of C5L2	change from baseline at 10 weeks

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Anticipated): March 1, 2013
• Study Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: November 21, 2011
• First Submitted That Met QC Criteria: November 22, 2011
• First Posted (Estimate): November 23, 2011

Study Record Updates

• Last Update Posted (Estimate): December 3, 2012
• Last Update Submitted That Met QC Criteria: November 30, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: ASP; LCN2; RBP4; C5L2
• Other Study ID Numbers: 15176