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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01478776
• Other study ID #: 15176
• Status: Unknown status
• Phase: Phase 4
• First received: November 21, 2011
• Last updated: November 30, 2012
• Start date: December 2011
• Est. completion date: September 2013

Study information

• Verified date: November 2012
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 20
• Est. completion date: September 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Dietary Supplement:
• omega-3
4 cap 1 gr omega-3 per day for 10 weeks
• placebo
patient with type 2 diabetes who receive 4 cap placebo/day for 10 weeks

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum total cholesterol		change from baseline at 10 weeks
Primary	serum High-density lipoprotein (HDL) cholesterol		change from baseline at 10 weeks
Primary	serum Low-density lipoprotein (LDL) cholesterol		change from baseline at 10 weeks
Primary	serum triglycerides (TG) level		change from baseline at 10 weeks
Primary	postprandial triglycerides		change from baseline at 10 weeks
Primary	complete blood count(CBC)		change from baseline at 10 weeks
Primary	fasting plasma glucose(FPG)		change from baseline at 10 weeks
Primary	Glycated hemoglobin (Hb A1c)		change from baseline at 10 weeks
Primary	acylation stimulating protein (ASP)		change from baseline at 10 weeks
Primary	lipocalin-2 (LCN2)		change from baseline at 10 weeks
Primary	Retinol-binding protein 4 (RBP4)		change from baseline at 10 weeks
Primary	non-esterified fatty acids (NEFA)		change from baseline at 10 weeks
Primary	insulin		change from baseline at 10 weeks
Primary	postprandial ASP		chage from baseline at 10 weeks
Secondary	gene expression of C5L2		change from baseline at 10 weeks