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

Tehran University of Medical Sciences

Status and phase: Unknown; Phase 4

Conditions: Type 2 Diabetes

Treatments: Dietary Supplement: placebo; Dietary Supplement: omega-3

Study type: Interventional

Funder types: Other

Identifiers

NCT01478776

15176

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

diabetes, omega-3

Active Comparator group

Description:

patient with type 2 diabetes who receive 4gr/day omega-3

Treatment:

Dietary Supplement: omega-3

placebo, diabetes

Placebo Comparator group

Description:

patient with type 2 diabetes who receive 4 cap of placebo/day

Treatment:

Dietary Supplement: placebo