Clinical trial NCT01478776: The Impact of Omega-3 Supplementation on Gene Expression in Type 2 Diabetics
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: ASP
LCN2
RBP4
C5L2
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-11-23
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: serum total cholesterol
timeFrame: change from baseline at 10 weeks
measure: serum High-density lipoprotein (HDL) cholesterol
timeFrame: change from baseline at 10 weeks
measure: serum Low-density lipoprotein (LDL) cholesterol
timeFrame: change from baseline at 10 weeks
measure: serum triglycerides (TG) level
timeFrame: change from baseline at 10 weeks
measure: postprandial triglycerides
timeFrame: change from baseline at 10 weeks
measure: complete blood count(CBC)
timeFrame: change from baseline at 10 weeks
measure: fasting plasma glucose(FPG)
timeFrame: change from baseline at 10 weeks
measure: Glycated hemoglobin (Hb A1c)
timeFrame: change from baseline at 10 weeks
measure: acylation stimulating protein (ASP)
timeFrame: change from baseline at 10 weeks
measure: lipocalin-2 (LCN2)
timeFrame: change from baseline at 10 weeks
measure: Retinol-binding protein 4 (RBP4)
timeFrame: change from baseline at 10 weeks
measure: non-esterified fatty acids (NEFA)
timeFrame: change from baseline at 10 weeks
measure: insulin
timeFrame: change from baseline at 10 weeks
measure: postprandial ASP
timeFrame: chage from baseline at 10 weeks
Secondary outcomes:
measure: gene expression of C5L2
timeFrame: change from baseline at 10 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran University of Medical Sciences
Study officials:
References: