NCT02701894

Brief Summary

With the emerging worldwide epidemic of type 2 diabetes, dietary recommendations to improve diabetes management have been emphasized in the scientific community. Particular attention has been drawn to various benefits of replacing saturated fatty acids with unsaturated fatty acids. Alpha-linolenic acid, the only omega-3 fatty acid that is from plant sources, has been suggested by animal and cell studies to play a beneficial role in regulating blood glucose levels. However, human studies have been more inconsistent with their findings. The focus of this project is to investigate the evidence in the context of ALA and blood glucose parameters in participants with type 2 diabetes by conducting a systematic review and meta-analysis of randomized controlled trials.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Typical duration for all trials

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

Study Start

First participant enrolled

December 1, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
Last Updated

March 8, 2016

Status Verified

March 1, 2016

Enrollment Period

3.2 years

First QC Date

March 2, 2016

Last Update Submit

March 2, 2016

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    1 month

Secondary Outcomes (5)

  • Fructosamine

    1 month

  • Fasting Blood Glucose

    1 month

  • Fasting Blood Insulin

    1 month

  • Glycated Albumin

    1 month

  • HOMA- IR

    1 month

Interventions

Alpha-Linolenic AcidDIETARY_SUPPLEMENT

Meta-Analysis of Randomized Controlled Trials

Also known as: ALA

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants with type 2 diabetes mellitus.

You may qualify if:

  • Controlled, randomized, clinical trials
  • Trials greater than one month
  • Focusing on ALA and T2DM participants
  • Viable endpoint data

You may not qualify if:

  • Non-human studies
  • Non-random treatment allocation
  • Less than 1 month
  • Lack of suitable control
  • Lack of endpoint data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

alpha-Linolenic Acid

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsLinolenic AcidsFatty Acids, EssentialFatty Acids, UnsaturatedFatty Acids

Study Officials

  • Vladimir Vuksan, PhD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist & Professor

Study Record Dates

First Submitted

March 2, 2016

First Posted

March 8, 2016

Study Start

December 1, 2012

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 8, 2016

Record last verified: 2016-03