ALA on Glycemic Control in T2DM Participants

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02701894
• Other study ID #: ALA and GC in T2D
• Status: Active, not recruiting
• Phase: N/A
• First received: March 2, 2016
• Last updated: March 2, 2016
• Start date: December 2012
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Alpha-Linolenic Acid
Meta-Analysis of Randomized Controlled Trials

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		1 month	No
Secondary	Fructosamine		1 month	No
Secondary	Fasting Blood Glucose		1 month	No
Secondary	Fasting Blood Insulin		1 month	No
Secondary	Glycated Albumin		1 month	No
Secondary	HOMA- IR		1 month	No