Type 2 DiabetesNCT02683135
Lifestyle Control of Postprandial Hyperglycemia
A study testing High-carbohydrate diet, Low-carbohydrate diet and Low-carbohydrate diet with post-meal walking in people with Type 2 Diabetes, run by University of British Columbia at 1 site in Canada.
Trial summary
Large spikes in blood glucose experienced after meals in people with type 2 diabetes are known to damage blood vessels. Low carbohydrate high fat diets and exercise can improve blood glucose control in people with type 2 diabetes but it is unclear how these two strategies interact to affect blood vessel function and… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- High-carbohydrate diet, Low-carbohydrate diet and Low-carbohydrate diet with post-meal walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2015to 1 Jun 2017
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 2 diabetes (at least 6 months ago)
- Aged 40-75
- Engaging in 2 or less moderate-to-vigorous exercise bouts per week in the last 3 months
- Ability to understand and communicate in English to interact with the personal trainer
Who cannot join
- Diagnosed coronary artery disease
- Any contraindications to exercise (e.g., musculoskeletal injury)
- Prior history of cardio- or cerebrovascular disease or myocardial infarction
- Hypertension that is not controlled by medication (systolic blood pressure (BP) >160 mmHg and/or diastolic BP >99 mmHg)
- Change in diabetes medications in the previous 6 months
- Diagnosed with peripheral neuropathy
- Taking exogenous insulin
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia, Okanagan.
Kelowna, British Columbia, V1V 1V7
About this study
Official title: Low-carbohydrate Diet, With or Without Exercise, for Improving Postprandial Glucose Control and Vascular Function in Type 2 Diabetes and Prediabetes.
Large spikes in blood glucose experienced after meals in people with type 2 diabetes are known to damage blood vessels. Low carbohydrate high fat diets and exercise can improve blood glucose control in people with type 2 diabetes but it is unclear how these two strategies interact to affect blood vessel function and inflammation. We will examine how following a short-term low carbohydrate high fat diet (4 days) with or without post-meal walking impacts markers of blood vessel function and inflammation. We will also examine how a single low carbohydrate high fat meal, with or without post-meal walking, impacts blood glucose control and blood vessel function. Findings will help determine the best lifestyle approach for improving cardiovascular health in type 2 diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- High-carbohydrate diet, Low-carbohydrate diet, Low-carbohydrate diet with post-meal walking
- 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.
High-carbohydrate dietBehavioural
Participants will engage in 4 days of high-carbohydrate low fat diet as recommended by the Canadian Diabetes Association. The macronutrients content will go as follow: 55% carbohydrate, 25% protein and 20% fat. Breakfast, lunch and dinner will be provided to the participants as part of an isoenergetic diet. Between interventions there will be at least a one-week washout, where participants are encouraged to return to their baseline dietary habits.
Low-carbohydrate dietBehavioural
Participants will engage in 4 days of low-carbohydrate high-fat diet. The macronutrients content will go as follow: 10% carbohydrate, 25% protein and 65% fat. Breakfast, lunch and dinner will be provided to the participants as part of an isoenergetic diet. Between interventions there will be at least a one-week washout, where participants are encouraged to return to their baseline dietary habits.
Low-carbohydrate diet with post-meal walkingBehavioural
Participants will follow the same diet as in the low-carbohydrate diet arm but also perform 15 minutes of walking beginning ~15 minutes after breakfast, lunch and dinner. Approximately 70 kcal (individualized) will be added to main meals to account for exercise energy expenditure. Between interventions there will be at least a one-week washout, where participants are encouraged to return to their baseline dietary habits.
| Study group | Role | What they receive |
|---|---|---|
| High-carbohydrate diet | Active comparator | Not described Receives: Behavioral: High-carbohydrate diet |
| Low-carbohydrate diet | Experimental | Not described Receives: Behavioral: Low-carbohydrate diet |
| Low-carbohydrate diet with post-meal walking | Experimental | Not described Receives: Behavioral: Low-carbohydrate diet; Behavioral: Low-carbohydrate diet with post-meal walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in glycemic control assessed by continuous glucose monitoring in low-carbohydrate, low-carbohydrate plus post-meal walking, and high-carbohydrate low-fat arm.
Measured: 4-day average glucose levels assessed in each arm.
Secondary outcomes (3)
Change from baseline in circulating inflammatory cytokines after 4 days of intervention.
Measured: Fasting measurements taken on day 1 and day 5.
Change from baseline in toll-like receptors 2 and 4 expression on white blood cells after 4 days of intervention.
Measured: Fasting measurements taken on day 1 and day 5.
Change from baseline in flow mediated dilation of brachial artery after 4 days of intervention.
Measured: Fasting measurements taken on day 1 and day 5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startNov 2015
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
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 British ColumbiaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Jonathan Little, University of British Columbia
- Investigators
- Jonathan P Little, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683135
- Sponsor's protocol ID
- H1501952
- Status last verified
- Aug 2017
- First submitted
- 11 Feb 2016
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-carbohydrate Diet, With or Without Exercise, for Improving Postprandial Glucose Control and Vascular Function in Type 2 Diabetes and Prediabetes.
- ClinicalTrials.gov ID
- NCT02683135
- Acronym / sponsor ID
- H1501952
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Nov 2015
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 17 Feb 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.
Large spikes in blood glucose experienced after meals in people with type 2 diabetes are known to damage blood vessels. Low carbohydrate high fat diets and exercise can improve blood glucose control in people with type 2 diabetes but it is unclear how these two strategies interact to affect blood vessel function and inflammation. We will examine how following a short-term low carbohydrate high fat diet (4 days) with or without post-meal walking impacts markers of blood vessel function and inflammation. We will also examine how a single low carbohydrate high fat meal, with or without post-meal walking, impacts blood glucose control and blood vessel function. Findings will help determine the best lifestyle approach for improving cardiovascular health in type 2 diabetes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-carbohydrate diet | Active comparator | Behavioral: High-carbohydrate diet |
| Low-carbohydrate diet | Experimental | Behavioral: Low-carbohydrate diet |
| Low-carbohydrate diet with post-meal walking | Experimental | Behavioral: Low-carbohydrate diet, Behavioral: Low-carbohydrate diet with post-meal walking |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with type 2 diabetes (at least 6 months ago)
- Aged 40-75
- Engaging in 2 or less moderate-to-vigorous exercise bouts per week in the last 3 months
- Ability to understand and communicate in English to interact with the personal trainer
Key exclusion criteria (7 listed)
- Diagnosed coronary artery disease
- Any contraindications to exercise (e.g., musculoskeletal injury)
- Prior history of cardio- or cerebrovascular disease or myocardial infarction
- Hypertension that is not controlled by medication (systolic blood pressure (BP) >160 mmHg and/or diastolic BP >99 mmHg)
- Change in diabetes medications in the previous 6 months
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 |
|---|---|---|
| High-carbohydrate dietParticipants will engage in 4 days of high-carbohydrate low fat diet as recommended by the Canadian Diabetes Association. The macronutrients content will go as follow: 55% carbohydrate, 25% protein and 20% fat. Breakfast, lunch and dinner will be provided to the participants as part of an isoenergetic diet. Between interventions there will be at least a one-week washout, where participants are encouraged to return to their baseline dietary habits. | Behavioural | High-carbohydrate diet |
| Low-carbohydrate dietParticipants will engage in 4 days of low-carbohydrate high-fat diet. The macronutrients content will go as follow: 10% carbohydrate, 25% protein and 65% fat. Breakfast, lunch and dinner will be provided to the participants as part of an isoenergetic diet. Between interventions there will be at least a one-week washout, where participants are encouraged to return to their baseline dietary habits. | Behavioural | Low-carbohydrate diet, Low-carbohydrate diet with post-meal walking |
| Low-carbohydrate diet with post-meal walkingParticipants will follow the same diet as in the low-carbohydrate diet arm but also perform 15 minutes of walking beginning ~15 minutes after breakfast, lunch and dinner. Approximately 70 kcal (individualized) will be added to main meals to account for exercise energy expenditure. Between interventions there will be at least a one-week washout, where participants are encouraged to return to their baseline dietary habits. | Behavioural | Low-carbohydrate diet with post-meal walking |
Primary outcome
Difference in glycemic control assessed by continuous glucose monitoring in low-carbohydrate, low-carbohydrate plus post-meal walking, and high-carbohydrate low-fat arm.
Time frame: 4-day average glucose levels assessed in each arm.
3 secondary outcomes
Change from baseline in circulating inflammatory cytokines after 4 days of intervention.
Time frame: Fasting measurements taken on day 1 and day 5.
Change from baseline in toll-like receptors 2 and 4 expression on white blood cells after 4 days of intervention.
Time frame: Fasting measurements taken on day 1 and day 5.
Change from baseline in flow mediated dilation of brachial artery after 4 days of intervention.
Time frame: Fasting measurements taken on day 1 and day 5.
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 3 Aug 2017.
- Individual participant dataSharing planned: No
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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.
Jonathan P Little, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-carbohydrate diet, Low-carbohydrate diet and Low-carbohydrate diet with post-meal walking in people with Type 2 Diabetes, run by University of British Columbia 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 4 inclusion and 7 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 3 Aug 2017. 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.
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?
Difference in glycemic control assessed by continuous glucose monitoring in low-carbohydrate, low-carbohydrate plus post-meal walking, and high-carbohydrate low-fat arm. (time frame: 4-day average glucose levels assessed in each arm.). 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 3 Aug 2017.