NCT01478776

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4 type-2-diabetes

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
8 days until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

December 3, 2012

Status Verified

November 1, 2012

Enrollment Period

1.2 years

First QC Date

November 21, 2011

Last Update Submit

November 30, 2012

Conditions

Type 2 Diabetes

Keywords

ASPLCN2RBP4C5L2

Outcome Measures

Primary Outcomes (14)

  • 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

  • postprandial ASP

    chage from baseline at 10 weeks

Secondary Outcomes (1)

  • gene expression of C5L2

    change from baseline at 10 weeks

Study Arms (2)

diabetes, omega-3

ACTIVE COMPARATOR

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

Dietary Supplement: omega-3

placebo, diabetes

PLACEBO COMPARATOR

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

Dietary Supplement: placebo

Interventions

omega-3DIETARY_SUPPLEMENT

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

Also known as: n-3 fatty acids,n-3 PUFA
diabetes, omega-3
placeboDIETARY_SUPPLEMENT

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

placebo, diabetes

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tehran University of Medical Sciences

Tehran, Tehran Province, Iran

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2011

First Posted

November 23, 2011

Study Start

December 1, 2011

Primary Completion

March 1, 2013

Study Completion

September 1, 2013

Last Updated

December 3, 2012

Record last verified: 2012-11

Locations

IR(1)