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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01478776
First received: November 21, 2011
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes
Dietary Supplement: omega-3
Dietary Supplement: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • serum total cholesterol [ Time Frame: change from baseline at 10 weeks ] [ Designated as safety issue: No ]
  • serum High-density lipoprotein (HDL) cholesterol [ Time Frame: change from baseline at 10 weeks ] [ Designated as safety issue: No ]
  • serum Low-density lipoprotein (LDL) cholesterol [ Time Frame: change from baseline at 10 weeks ] [ Designated as safety issue: No ]
  • serum triglycerides (TG) level [ Time Frame: change from baseline at 10 weeks ] [ Designated as safety issue: No ]
  • postprandial triglycerides [ Time Frame: change from baseline at 10 weeks ] [ Designated as safety issue: No ]
  • complete blood count(CBC) [ Time Frame: change from baseline at 10 weeks ] [ Designated as safety issue: No ]
  • fasting plasma glucose(FPG) [ Time Frame: change from baseline at 10 weeks ] [ Designated as safety issue: No ]
  • Glycated hemoglobin (Hb A1c) [ Time Frame: change from baseline at 10 weeks ] [ Designated as safety issue: No ]
  • acylation stimulating protein (ASP) [ Time Frame: change from baseline at 10 weeks ] [ Designated as safety issue: No ]
  • lipocalin-2 (LCN2) [ Time Frame: change from baseline at 10 weeks ] [ Designated as safety issue: No ]
  • Retinol-binding protein 4 (RBP4) [ Time Frame: change from baseline at 10 weeks ] [ Designated as safety issue: No ]
  • non-esterified fatty acids (NEFA) [ Time Frame: change from baseline at 10 weeks ] [ Designated as safety issue: No ]
  • insulin [ Time Frame: change from baseline at 10 weeks ] [ Designated as safety issue: No ]
  • postprandial ASP [ Time Frame: chage from baseline at 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • gene expression of C5L2 [ Time Frame: change from baseline at 10 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: diabetes, omega-3
patient with type 2 diabetes who receive 4gr/day omega-3
Dietary Supplement: omega-3
4 cap 1 gr omega-3 per day for 10 weeks
Other Name: n-3 fatty acids,n-3 PUFA
Placebo Comparator: placebo, diabetes
patient with type 2 diabetes who receive 4 cap of placebo/day
Dietary Supplement: placebo
patient with type 2 diabetes who receive 4 cap placebo/day for 10 weeks

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

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01478776

Locations
Iran, Islamic Republic of
Tehran University of Medical Sciences
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
  More Information

No publications provided

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01478776     History of Changes
Other Study ID Numbers: 15176
Study First Received: November 21, 2011
Last Updated: November 30, 2012
Health Authority: Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:
ASP
LCN2
RBP4
C5L2

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 21, 2014