Type 2 DiabetesNCT00223574
Canadian Trial of Dietary Carbohydrates in Diabetes
A study testing high carbohydrate, low glycemic index foods and low carbohydrate, high monounsaturate fat foods in people with Type 2 Diabetes, run by University of Toronto at 5 sites in Canada.
Trial summary
A long-term low carbohydrate, high monounsaturated fat diet, compared to a high carbohydrate, low glycemic index diet, results in more rapid progression of diabetes; i.e. increased fasting glucose and glycated hemoglobin, reduced beta-cell function and insulin sensitivity and increased free fatty acids. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- high carbohydrate, low glycemic index foods and low carbohydrate, high monounsaturate fat foods
- How many people
- 168 participants
- Where
- 5 sitesCanada
- Study dates
- Jan 2002to Oct 2004
- Phase
- Interventional
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or non-pregnant/non-lactating females with type 2 diabetes treated by diet alone
- age 53-75y
- body mass index 25-40kg/m^2 (Caucasian) or 23-40kg/m^2 (other)
- HbA1c <=130% of upper limit of normal of local hospital lab
Who cannot join
- use of any hypoglycemic or anti-hyperglycemic drug within 6 months of randomization
- major cardiovascular event or major surgery within 6 months of randomization
- serum triglycerides >10mmol/L
- presence of other major debilitating disorder such as liver disease, renal failure or cancer
- presence of gastrointestinal disorder or use of drug which is likely to alter gastrointestinal motility or nutrient absorption
- use of oral steroids
Show all 11Show fewer
- substance or alcohol abuse
- simultaneous participation in another clinical trial
- allergy or intolerance to more than one of wheat, barley, corn, oats, potato, legumes, nuts, psyllium, olives, avocado or canola
- unwilling or unable to follow the protocol and/or give informed consent
- subjects planning to be on holiday for more than 8 weeks in a row or a total of 12 weeks in the year in locations to which they will not take study food
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Clinical Trials Centre
Edmonton, Alberta, T6G 2C8
St. Joseph's Health Centre
London, Ontario, N6G 2M3
Hotel Dieu
Montreal, Quebec, H2W 1T8
Centre Universitaire de Sante de l'estrie
Sherbrooke, Quebec, J1H 5N4
St. Michael's Hosptial
Toronto, Ontario, M5B 1W8
About this study
Official title: Long-Term Effect of Altering the Source or Amount of Dietary Carbohydrate in Type 2 Diabetes
A long-term low carbohydrate, high monounsaturated fat diet, compared to a high carbohydrate, low glycemic index diet, results in more rapid progression of diabetes; i.e. increased fasting glucose and glycated hemoglobin, reduced beta-cell function and insulin sensitivity and increased free fatty acids. The deleterious effects of a high carbohydrate diet on plasma lipids are only temporary and do not persist beyond 6 months. A long-term high carbohydrate, low glycemic index diet, compared to a high carbohydrate, high glycemic index diet, improves glycemic control and beta-cell function
- Conditions
- Type 2 Diabetes
- Being tested
- Control - high carbohydrate, high glycemic index foods, high carbohydrate, low glycemic index foods, low carbohydrate, high monounsaturate fat foods
- 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.
Control - high carbohydrate, high glycemic index foodsDrug
high carbohydrate, low glycemic index foodsDrug
low carbohydrate, high monounsaturate fat foodsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
glycated hemoglobin
Secondary outcomes (16)
Body weight
waist circumference
occurrence of diet failure
fasting glucose
fasting C-reactive protein
fasting lipids (total, HDL and LDL cholesterol and triglcyerides)
fasting apolipoproteins A1 and B100
fasting free fatty acids
fasting short chain fatty acids
plasma glucose and insulin 30, 60 and 120min after 75g oral glucose
insulin sensitivity (HOMA)
beta-cell function (30min-fasting insulin)/(30min-fasting glucose)
metabolic profile (glucose, insulin, triglycerides and FFA during 8h profile)
quality of life
gastrointestinal symptoms
diet satisfactio
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJan 2002
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 168 participants
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Thomas MS Wolever, MD, PhD, Principal investigator, University of Toronto/St. Michael's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223574
- Sponsor's protocol ID
- 44205
- Status last verified
- Sep 2005
- First submitted
- 20 Sep 2005
- Last updated
- 22 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Effect of Altering the Source or Amount of Dietary Carbohydrate in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00223574
- Acronym / sponsor ID
- 44205
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Jan 2002
- Study completion
- Oct 2004
- First posted
- 22 Sep 2005 (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.
A long-term low carbohydrate, high monounsaturated fat diet, compared to a high carbohydrate, low glycemic index diet, results in more rapid progression of diabetes; i.e. increased fasting glucose and glycated hemoglobin, reduced beta-cell function and insulin sensitivity and increased free fatty acids. The deleterious effects of a high carbohydrate diet on plasma lipids are only temporary and do not persist beyond 6 months. A long-term high carbohydrate, low glycemic index diet, compared to a high carbohydrate, high glycemic index diet, improves glycemic control and beta-cell function
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male or non-pregnant/non-lactating females with type 2 diabetes treated by diet alone
- age 53-75y
- body mass index 25-40kg/m^2 (Caucasian) or 23-40kg/m^2 (other)
- HbA1c <=130% of upper limit of normal of local hospital lab
Key exclusion criteria (11 listed)
- use of any hypoglycemic or anti-hyperglycemic drug within 6 months of randomization
- major cardiovascular event or major surgery within 6 months of randomization
- serum triglycerides >10mmol/L
- presence of other major debilitating disorder such as liver disease, renal failure or cancer
- presence of gastrointestinal disorder or use of drug which is likely to alter gastrointestinal motility or nutrient absorption
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 |
|---|---|---|
| Control - high carbohydrate, high glycemic index foods | Drug | – |
| high carbohydrate, low glycemic index foods | Drug | – |
| low carbohydrate, high monounsaturate fat foods | Drug | – |
Primary outcome
glycated hemoglobin
16 secondary outcomes
Body weight
waist circumference
occurrence of diet failure
fasting glucose
fasting C-reactive protein
fasting lipids (total, HDL and LDL cholesterol and triglcyerides)
fasting apolipoproteins A1 and B100
fasting free fatty acids
fasting short chain fatty acids
plasma glucose and insulin 30, 60 and 120min after 75g oral glucose
insulin sensitivity (HOMA)
beta-cell function (30min-fasting insulin)/(30min-fasting glucose)
metabolic profile (glucose, insulin, triglycerides and FFA during 8h profile)
quality of life
gastrointestinal symptoms
diet satisfactio
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 22 Sep 2005.
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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.
Thomas MS Wolever, MD, PhD principal investigator
University of Toronto/St. Michael's Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high carbohydrate, low glycemic index foods and low carbohydrate, high monounsaturate fat foods in people with Type 2 Diabetes, run by University of Toronto at 5 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 4 inclusion and 11 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 22 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
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?
glycated hemoglobin. 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 22 Sep 2005.