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Type 2 DiabetesPhase 2NCT01063374

Low Glycemic Index Diet for Type 2 Diabetics

A Phase 2 study testing low glycemic diet instruction and high cereal fibre diet instruction in people with Type 2 Diabetes, run by University of Toronto at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A low glycemic index diet may improve glycemic control and reduce plaque buildup in arteries of those with type 2 diabetes. Subjects will be randomly assigned to receive dietary advice on either a low glycemic index diet, or a high cereal fibre diet, for three years. 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 diet instruction and high cereal fibre diet instruction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
169 participants
Where
2 sitesCanada
Study dates
Mar 2010to Aug 2016
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

  • Men and women with type 2 diabetes who
  • 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 8.0% at screening and at the prestudy visit
  • have diabetes diagnosed >6 months
  • have maintained stable weight for 2 months (within 3%)
  • have a valid OHIP card and a family physician
Show all 9Show fewer
  • 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 19Show 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
  • If HbA1c rises above 8.5% over two consecutive routine measurements, subjects will be referred back to their family doctors for an increase in anti hyperglycemic medications according to a predetermined protocol.
  • Any condition or circumstance which would prevent an individual from having an MRI (e.g. individuals with prostheses or metal implants, or those who are excessively claustrophobic)

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Clinical Nutrition & Risk Factor Modification Centre, St. Michael's Hospital Health Centre

    Toronto, Ontario, M5C 2T2

Other trials in Canada

About this study

Official title: Low Glycemic Index Diets to Improve Glycemic Control and Cardiovascular Disease in Type 2 Diabetics

A low glycemic index diet may improve glycemic control and reduce plaque buildup in arteries of those with type 2 diabetes. Subjects will be randomly assigned to receive dietary advice on either a low glycemic index diet, or a high cereal fibre diet, for three years.

Read the detailed description

All subjects will be randomized to one 3-year treatment in a two-treatment parallel design.

Treatments:

  1. low glycemic index dietary advice (e.g. to eat intact grain cereals, parboiled rice, cracked wheat, pasta, peas, beans, lentils, and baked goods made from legume flour); or
  2. a high cereal fiber diet emphasizing whole grains. Duration: The study will consist of approximately two months of recruitment and patient selection, during which time estimation of individual caloric requirements will be assessed, and a 3 year treatment period assigned.

Study Details: Fasting blood samples are obtained at screening, week -2, and months 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 each study period. HbA1c will be assessed on all visits. A carotid ultrasound (CUS) (screening, months 0, 12 and 36) and magnetic resonance imaging (MRI) (months 0, 12 and 36) technologies will be used to assess arterial wall thickening and changes in the nature of carotid plaques. Twenty-four hour urine for urinary C-peptide analyses will be obtained immediately prior to the beginning of the study and at the end of each 3 year treatment phase. At the end of the 3 year treatment period, subjects who wish to undertake the alternate treatment will be given appropriate instruction.

Conditions
Type 2 Diabetes
Being tested
low glycemic diet instruction, high cereal fibre diet instruction
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 diet instructionDietary supplement

  • high cereal fibre diet instructionDietary supplement

Study groups in NCT01063374
Study groupRoleWhat they receive
low glycemic index, diabetic dietActive comparatorlow glycemic index, diabetic diet
Receives: Dietary Supplement: low glycemic diet instruction
high cereal fibre, diabetic dietActive comparatorhigh cereal fibre, diabetic diet
Receives: Dietary Supplement: high cereal fibre diet instruction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. plaque volume

    Measured: 1, 3 years

Secondary outcomes (8)

  1. intima media thickness

    Measured: 0, 1, and 3 years

  2. plaque morphology

    Measured: 0, 1, 3 years

  3. HbA1c

    Measured: every 3 months for 3 years

  4. serum lipids

    Measured: every 3 months for 3 years

  5. blood pressure

    Measured: every 3 months for 3 years

  6. serum fasting glucose

    Measured: creatinine, urea, and C-peptides in 24 hour urine collection

  7. anthropometric measures (weight, waist and hip circumference)

    Measured: every 3 months for 3 years

  8. retinal photography

    ophthalmological assessment using fundoscopy

    Measured: 1, 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionJul 2016
  4. Study completionAug 2016

Resources

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
169 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01063374
Sponsor's protocol ID
09-193
Status last verified
Sep 2016
First submitted
3 Feb 2010
Last updated
14 Sep 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Chiavaroli L, Mirrahimi A, Ireland C, Mitchell S, Sahye-Pudaruth S, Coveney J, Olowoyeye O, Patel D, de Souza RJ, Augustin LS, Bashyam B, Pichika SC, Blanco Mejia S, Nishi SK, Leiter LA, Josse RG, McKeown-Eyssen GE, Moody AR, Kendall CW, Sievenpiper JL, Jenkins DJ. Cross-sectional associations between dietary intake and carotid intima media thickness in type 2 diabetes: baseline data from a randomised trial. BMJ Open. 2017 Mar 22;7(3):e015026. doi: 10.1136/bmjopen-2016-015026.

    PubMed 28336747

  • Chiavaroli L, Mirrahimi A, Ireland C, Mitchell S, Sahye-Pudaruth S, Coveney J, Olowoyeye O, Maraj T, Patel D, de Souza RJ, Augustin LS, Bashyam B, Blanco Mejia S, Nishi SK, Leiter LA, Josse RG, McKeown-Eyssen G, Moody AR, Berger AR, Kendall CW, Sievenpiper JL, Jenkins DJ. Low-glycaemic index diet to improve glycaemic control and cardiovascular disease in type 2 diabetes: design and methods for a randomised, controlled, clinical trial. BMJ Open. 2016 Jul 7;6(7):e012220. doi: 10.1136/bmjopen-2016-012220.

    PubMed 27388364

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing low glycemic diet instruction and high cereal fibre diet instruction in people with Type 2 Diabetes, run by University of Toronto at 2 sites 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 9 inclusion and 19 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 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

plaque volume (time frame: 1, 3 years). 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 NCT01063374, which also lists 2 linked publications.

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 14 Sep 2016.

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