Type 2 Diabetes MellitusNCT02701894
ALA on Glycemic Control in T2DM Participants
An observational study of Type 2 Diabetes Mellitus, run by Unity Health Toronto.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Alpha-Linolenic Acid
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with type 2 diabetes mellitus.
Who may be able to join
- Controlled, randomized, clinical trials
- Trials greater than one month
- Focusing on ALA and T2DM participants
- Viable endpoint data
Who cannot join
- Non-human studies
- Non-random treatment allocation
- Less than 1 month
- Lack of suitable control
- Lack of endpoint data
About this study
Official title: 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Alpha-Linolenic Acid
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-Linolenic AcidDietary supplement
Also called ALA
Meta-Analysis of Randomized Controlled Trials
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: 1 month
Secondary outcomes (5)
Fructosamine
Measured: 1 month
Fasting Blood Glucose
Measured: 1 month
Fasting Blood Insulin
Measured: 1 month
Glycated Albumin
Measured: 1 month
HOMA- IR
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startDec 2012
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vladimir Vuksan, Unity Health Toronto
- Investigators
- Vladimir Vuksan, PhD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701894
- Sponsor's protocol ID
- ALA and GC in T2D
- Status last verified
- Mar 2016
- First submitted
- 2 Mar 2016
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Alpha-Linolenic Acid on Glycemic Control in Participants With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02701894
- Acronym / sponsor ID
- ALA and GC in T2D
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with type 2 diabetes mellitus.
Key inclusion criteria (4 listed)
- Controlled, randomized, clinical trials
- Trials greater than one month
- Focusing on ALA and T2DM participants
- Viable endpoint data
Key exclusion criteria (5 listed)
- Non-human studies
- Non-random treatment allocation
- Less than 1 month
- Lack of suitable control
- Lack of endpoint data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha-Linolenic AcidAlso: ALAMeta-Analysis of Randomized Controlled Trials | Dietary supplement | – |
Primary outcome
HbA1c
Time frame: 1 month
5 secondary outcomes
Fructosamine
Time frame: 1 month
Fasting Blood Glucose
Time frame: 1 month
Fasting Blood Insulin
Time frame: 1 month
Glycated Albumin
Time frame: 1 month
HOMA- IR
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir Vuksan, PhD principal investigator
Unity Health Toronto
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by Unity Health Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016.