Type 2 DiabetesPhase 2NCT01063361
Low Glycemic Index Diets (With Pulses) in Type 2 Diabetes
A Phase 2 study testing Low glycemic index diet with pulses and High Cereal Fibre in people with Type 2 Diabetes, run by University of Toronto at 1 site in Canada.
Trial summary
Healthy individuals with type 2 diabetes will receive intensive counseling on food selection to improve glucose control using either high cereal fiber dietary strategies or low glycemic index foods emphasizing dried legumes and their products. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Low glycemic index diet with pulses and High Cereal Fibre
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2010to Aug 2015
- Phase
- Phase 2
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are treated with oral hypoglycemic agents at a stable dose for at least 8 weeks
- have a HbA1c in the range of 6.5% to 8.5% at screening and at the visit prior to randomization
- have diabetes diagnosed >6 months
- have maintained stable weight for 2 months (within 3%)
- have a valid OHIP card and a family physician
- if prescribed lipid medication, have taken a stable dose for at least 2 weeks
- if prescribed blood pressure medication, have taken a stable dose for at least 1 week
- can keep written food records, with the use of a digital scale
Who cannot join
- take insulin
- take steroids
- have GI disease (gastroparesis, celiac disease, ulcerative colitis, Crohn's Disease, IBS)
- have had a major cardiovascular event (stroke or myocardial infarction) in the past 6 months
- take warfarin (Coumadin)
- have had major surgery in the past 6 months
Show all 17Show fewer
- have a major debilitating disorder
- have clinically significant liver disease (AST or ALT > 130 U/L), excluding NAFL or NASH
- have hepatitis B or C
- have renal failure (high creatinine > 150 mmol/L)
- have serum triglycerides ≥ 6.0 mmol/L
- have a history of cancer, except non-melanoma skin cancer (basal cell, squamous cell)
- have food allergies to study food components
- have elevated blood pressure (> 145/90) unless approved by GP
- have acute or chronic infections (bacterial or viral)
- have chronic inflammatory diseases (e.g. rheumatoid arthritis, lupus; ulcerative colitis)
- have other conditions which in the opinion of any of the investigators would make them unsuitable for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Low Glycemic Index Diets (With Pulses) on Glucose Control in Non-Insulin Dependent Diabetics
Healthy individuals with type 2 diabetes will receive intensive counseling on food selection to improve glucose control using either high cereal fiber dietary strategies or low glycemic index foods emphasizing dried legumes and their products. The treatments will last 3 months with bloods taken for HbA1c, glucose and blood lipids. If the study shows a benefit for either or both diets, then use of high fiber and/or low glycemic index foods in the diet may provide another potential way to improve glucose control and lower cholesterol levels in non-insulin dependent diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- Low glycemic index diet with pulses, High Cereal Fibre
- 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.
Low glycemic index diet with pulsesDietary supplement
Subjects will be advised to follow a diabetic diet, using low glycemic index foods, emphasizing pulses.
High Cereal FibreDietary supplement
Subjects will be advised to follow a healthy high fibre diabetic diet.
| Study group | Role | What they receive |
|---|---|---|
| Low glycemic Index Diet | Experimental | Low glycemic Index Diet, emphasizing pulses Receives: Dietary Supplement: Low glycemic index diet with pulses |
| High Cereal Fibre Diet | Active comparator | Not described Receives: Dietary Supplement: High Cereal Fibre |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in HbA1c
Measured: from prestudy and week 0, to end of treatment weeks 8, 10, and 12
serum lipids
Measured: from prestudy and week 0, to end of treatment weeks 8, 10, and 12
Secondary outcomes (4)
fasting glucose
Measured: from prestudy and week 0, to end of treatment weeks 8, 10, and 12
change in weight, waist and hip circumference
Measured: weeks 0, 12
blood pressure
Measured: from prestudy and week 0, to end of treatment weeks 8, 10, and 12
creatine, urea, and c-peptides in 24 hour urine collection
Measured: 0, 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionAug 2011
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatchewan Pulse Growers, Pulse Canada
- Responsible party
- Principal investigator, David Jenkins, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063361
- Sponsor's protocol ID
- 09-192
- Status last verified
- Dec 2015
- First submitted
- 3 Feb 2010
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jenkins DJ, Kendall CW, Augustin LS, Mitchell S, Sahye-Pudaruth S, Blanco Mejia S, Chiavaroli L, Mirrahimi A, Ireland C, Bashyam B, Vidgen E, de Souza RJ, Sievenpiper JL, Coveney J, Leiter LA, Josse RG. Effect of legumes as part of a low glycemic index diet on glycemic control and cardiovascular risk factors in type 2 diabetes mellitus: a randomized controlled trial. Arch Intern Med. 2012 Nov 26;172(21):1653-60. doi: 10.1001/2013.jamainternmed.70.
PubMed 23089999
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Glycemic Index Diets (With Pulses) on Glucose Control in Non-Insulin Dependent Diabetics
- ClinicalTrials.gov ID
- NCT01063361
- Acronym / sponsor ID
- 09-192
- Conditions
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Saskatchewan Pulse Growers, Pulse Canada
- Study start
- Feb 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 5 Feb 2010 (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.
Healthy individuals with type 2 diabetes will receive intensive counseling on food selection to improve glucose control using either high cereal fiber dietary strategies or low glycemic index foods emphasizing dried legumes and their products. The treatments will last 3 months with bloods taken for HbA1c, glucose and blood lipids. If the study shows a benefit for either or both diets, then use of high fiber and/or low glycemic index foods in the diet may provide another potential way to improve glucose control and lower cholesterol levels in non-insulin dependent diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low glycemic Index Diet | Experimental | Dietary Supplement: Low glycemic index diet with pulsesLow glycemic Index Diet, emphasizing pulses |
| High Cereal Fibre Diet | Active comparator | Dietary Supplement: High Cereal Fibre |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- are treated with oral hypoglycemic agents at a stable dose for at least 8 weeks
- have a HbA1c in the range of 6.5% to 8.5% at screening and at the visit prior to randomization
- have diabetes diagnosed >6 months
- have maintained stable weight for 2 months (within 3%)
- have a valid OHIP card and a family physician
Key exclusion criteria (17 listed)
- take insulin
- take steroids
- have GI disease (gastroparesis, celiac disease, ulcerative colitis, Crohn's Disease, IBS)
- have had a major cardiovascular event (stroke or myocardial infarction) in the past 6 months
- take warfarin (Coumadin)
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 |
|---|---|---|
| Low glycemic index diet with pulsesSubjects will be advised to follow a diabetic diet, using low glycemic index foods, emphasizing pulses. | Dietary supplement | Low glycemic Index Diet |
| High Cereal FibreSubjects will be advised to follow a healthy high fibre diabetic diet. | Dietary supplement | High Cereal Fibre Diet |
Primary outcome
change in HbA1c
Time frame: from prestudy and week 0, to end of treatment weeks 8, 10, and 12
serum lipids
Time frame: from prestudy and week 0, to end of treatment weeks 8, 10, and 12
4 secondary outcomes
fasting glucose
Time frame: from prestudy and week 0, to end of treatment weeks 8, 10, and 12
change in weight, waist and hip circumference
Time frame: weeks 0, 12
blood pressure
Time frame: from prestudy and week 0, to end of treatment weeks 8, 10, and 12
creatine, urea, and c-peptides in 24 hour urine collection
Time frame: 0, 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2015.
- Derived from this study: PubMed 23089999Jenkins DJ, Kendall CW, Augustin LS, Mitchell S, Sahye-Pudaruth S, Blanco Mejia S, Chiavaroli L, Mirrahimi A, Ireland C, Bashyam B, Vidgen E, de Souza RJ, Sievenpiper JL, Coveney J, Leiter LA, Josse RG. Effect of legumes as part of a low glycemic index diet on glycemic control and cardiovascular risk factors in type 2 diabetes mellitus: a randomized controlled trial. Arch Intern Med. 2012 Nov 26;172(21):1653-60. doi: 10.1001/2013.jamainternmed.70.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low glycemic index diet with pulses and High Cereal Fibre in people with Type 2 Diabetes, run by University of Toronto at 1 site in Canada.
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 8 inclusion and 17 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: finished, as of the sponsor's last update on 8 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change in HbA1c (time frame: from prestudy and week 0, to end of treatment weeks 8, 10, and 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01063361, which also lists 1 linked publication.
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 Dec 2015.