ALA on Glycemic Control in T2DM Participants

March 2, 2016 updated by: Vladimir Vuksan, Unity Health Toronto

The Effect of Alpha-Linolenic Acid on Glycemic Control in Participants With Type 2 Diabetes

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants with type 2 diabetes mellitus.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Fructosamine
Time Frame: 1 month
1 month
Fasting Blood Glucose
Time Frame: 1 month
1 month
Fasting Blood Insulin
Time Frame: 1 month
1 month
Glycated Albumin
Time Frame: 1 month
1 month
HOMA- IR
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

March 2, 2016

First Submitted That Met QC Criteria

March 2, 2016

First Posted (Estimate)

March 8, 2016

Study Record Updates

Last Update Posted (Estimate)

March 8, 2016

Last Update Submitted That Met QC Criteria

March 2, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALA and GC in T2D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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