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

Phase 4

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: omega-3; Dietary Supplement: placebo

• Registration Number: NCT01478776
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

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

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 Timeline

• Study First Submitted: 2011-11-21
• Study First Submitted QC: 2011-11-22
• Study First Posted: 2011-11-23
• Study Start: 2011-12
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-30
• Last Update Posted: 2012-12-03
• Primary Completion: 2013-03
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
diabetes, omega-3	omega-3	patient with type 2 diabetes who receive 4gr/day omega-3
placebo, diabetes	placebo	patient with type 2 diabetes who receive 4 cap of placebo/day

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
gene expression of C5L2	change from baseline at 10 weeks

Trial Locations

Locations (1)

Tehran University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of