We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Tehran University of Medical Sciences.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01478776
First Posted: November 23, 2011
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tehran University of Medical Sciences
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
  • serum High-density lipoprotein (HDL) cholesterol [ Time Frame: change from baseline at 10 weeks ]
  • serum Low-density lipoprotein (LDL) cholesterol [ Time Frame: change from baseline at 10 weeks ]
  • serum triglycerides (TG) level [ Time Frame: change from baseline at 10 weeks ]
  • postprandial triglycerides [ Time Frame: change from baseline at 10 weeks ]
  • complete blood count(CBC) [ Time Frame: change from baseline at 10 weeks ]
  • fasting plasma glucose(FPG) [ Time Frame: change from baseline at 10 weeks ]
  • Glycated hemoglobin (Hb A1c) [ Time Frame: change from baseline at 10 weeks ]
  • acylation stimulating protein (ASP) [ Time Frame: change from baseline at 10 weeks ]
  • lipocalin-2 (LCN2) [ Time Frame: change from baseline at 10 weeks ]
  • Retinol-binding protein 4 (RBP4) [ Time Frame: change from baseline at 10 weeks ]
  • non-esterified fatty acids (NEFA) [ Time Frame: change from baseline at 10 weeks ]
  • insulin [ Time Frame: change from baseline at 10 weeks ]
  • postprandial ASP [ Time Frame: chage from baseline at 10 weeks ]

Secondary Outcome Measures:
  • gene expression of C5L2 [ Time Frame: change from baseline at 10 weeks ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01478776     History of Changes
Other Study ID Numbers: 15176
First Submitted: November 21, 2011
First Posted: November 23, 2011
Last Update Posted: October 12, 2017
Last Verified: November 2012

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