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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01478776

Enrollment

Registered

2011-11-23

Start date

2011-12-31

Completion date

2013-09-30

Last updated

2012-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

ASP, LCN2, RBP4, C5L2

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.

Interventions

DIETARY_SUPPLEMENTomega-3

4 cap 1 gr omega-3 per day for 10 weeks

DIETARY_SUPPLEMENTplacebo

patient with type 2 diabetes who receive 4 cap placebo/day for 10 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
postprandial ASP	chage from baseline at 10 weeks
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

Secondary

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

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026