Type 1 DiabetesNCT04084418
Carbohydrates Under Target for Type 1 Diabetes Management
A study testing VLCHF Diet in people with Type 1 Diabetes, run by McGill University at 1 site in Canada.
Trial summary
Recently there has been an increased interest in limiting intake of carbohydrates (CHO) for improving long term health. While healthcare professionals (HCPs) are sometimes reluctant to limit the CHO intake due to the lack of information related to safety issues, low CHO diets are increasing in popularity amongst both… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- VLCHF Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2019to 23 Mar 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Duration of Type 1 Diabetes > 12 months
- On intensive insulin therapy for > 6 months
- Own a smartphone or tablet to use two mobile applications : Keenoa and Piezo: Achieve the Guidelines!
Who cannot join
- Known gastroparesis (clinical diagnosis)
- Advanced kidney disease (eGFR < 50 mL/min)
- Known significant liver disease (e.g., cirrhosis, active hepatitis, liver transplantation)
- Recent (< 6 months) major cardiovascular even (e.g. myocardial infarction, cerebrovascular accident, major revascularization, etc.)
- Pregnancy (ongoing or planned in the next 6 months)
- Breastfeeding
- Severe hypoglycemia episodes or ketoacidosis in the 4 weeks prior to recruitment
- Claustrophobia or presence of metal devices/implants in the body
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut de recherches cliniques de Montréal
Montreal, Quebec, H2W1R7
About this study
Recently there has been an increased interest in limiting intake of carbohydrates (CHO) for improving long term health. While healthcare professionals (HCPs) are sometimes reluctant to limit the CHO intake due to the lack of information related to safety issues, low CHO diets are increasing in popularity amongst both people with and without diabetes. One of these diets, the very low CHO high fat diet (VLCHF) raises concern on its impact on the lipid profile, liver, response to glucagon, and insulin dose adjustments when adopting it in the context of type 1 diabetes (T1D). The investigators recently conducted a series of interviews with people with diabetes following a VLCHF diet (Brazeau et al. Manuscript in preparation) to inquire on their reasons for adopting VLCHF as well as challenges they faced. The main reasons to initiate the diet were to limit blood glucose fluctuations and reduce medication. An issue that was frequently mentioned during the interviews was the lack of support from HCPs which often leads to not discussing it with said HCP. This is an important source of concern that can lead to additional safety issues. Our goal is to provide information regarding the safety of a VLCHF diet for T1D and the individualized insulin adjustments required.
The investigators aim to evaluate the changes in daily blood glucose fluctuations after 6 weeks of a VLCHF diet, to monitor the changes in the insulin dosing and to measure impact on lipid profiles, response to glucagon, and liver function.
- Conditions
- Type 1 Diabetes
- Being tested
- Control Diet, VLCHF Diet
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control DietOther
Participants will be provided with a two-week menu to be consumed 3 times for each intervention, for a total of 6 weeks per intervention. For the Control diet, the diet will provide 50% of energy from CHO, 15% from protein, and 35% from lipids. Menu will be adapted to the participant's food preferences and usual caloric intake by a dietitian. Participants will be asked to limit their alcohol intake in both interventions. During this phase, participants will also have to wear a pedometer and use the Pezio: Achieve the Guidelines! mobile application to help the research assistant track their daily steps remotely.
VLCHF DietOther
Participants will be provided with a two-week menu to be consumed 3 times for each intervention, for a total of 6 weeks per intervention. For the Experimental diet, the diet will provide 10% of energy from CHO, 15% from protein, and 75% from lipids. During the Experimental diet, participants will be provided with a multivitamin to reduce risk of deficiencies due to restrictions on fruits and grain products. Menu will be adapted to the participant's food preferences and usual caloric intake by a dietitian. Participants will be asked to limit their alcohol intake in both interventions. During this phase, participants will also have to wear a pedometer and use the Pezio: Achieve the Guidelines! mobile application to help the research assistant track their daily steps remotely.
| Study group | Role | What they receive |
|---|---|---|
| Control diet followed by VLCHF diet | Experimental | * Phase 1 (1 to 3 weeks): Insulin dose optimization with usual diet
* Phase 2 (6 weeks): Control diet (50% of energy from carbohydrates)
* Phase 3 (4 weeks): Washout period
* Phase 4 (6 weeks): VLCHF diet (10% of energy from carbohydrates) Receives: Other: Control Diet; Other: VLCHF Diet |
| VLCHF diet followed by Control diet | Experimental | * Phase 1 (1 to 3 weeks): Insulin dose optimization with usual diet
* Phase 2 (6 weeks): VLCHF diet (10% of energy from carbohydrates)
* Phase 3 (4 weeks): Washout period
* Phase 4 (6 weeks): Control diet (50% of energy from carbohydrates) Receives: Other: Control Diet; Other: VLCHF Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily blood glucose standard deviation
Using continuous glucose monitoring
Measured: Over the 6 weeks of each intervention diet
Secondary outcomes (27)
Percentage of time-in-target (range of 4-10 mmol/L)
Using continuous glucose monitoring
Measured: Over the 6 weeks of each intervention diet
Coefficient of glucose variation
Using continuous glucose monitoring
Measured: Over the 6 weeks of each intervention diet
Mean sensor glucose values (mmol/L)
Using continuous glucose monitoring
Measured: Over the 6 weeks of each intervention diet
Glucose area under the curve for 2 hours post-prandial
Using continuous glucose monitoring
Measured: First and last week of each intervention diet
Number of hypoglycemia episodes necessitating treatment recorded
Recorded by participants on hypoglycemia journal
Measured: Over the 6 weeks of each intervention diet
Percentage of time spent in hypoglycemia ranges (< 4 mmol/L and < 3 mmol/L)
Using continuous glucose monitoring
Measured: Over the 6 weeks of each intervention diet
Percentage of time spent in hyperglycemia ranges (>10 mmol/L and > 15 mmol/L)
Using continuous glucose monitoring
Measured: Over the 6 weeks of each intervention diet
Daily insulin adjustments required to maintain safe blood glucose
Adjustments (basal and prandial) to avoid hypoglycemia (blood glucose < 4 mmol/L) and hyperglycemia (blood glucose > 15 mmol/L)
Measured: Over the 6 weeks of each intervention diet
Short-term effects on anthropometric parameters : weight (kg) and height (cm)
Weight and height will be combined to report BMI (kg/m^2)
Measured: Following the 6 weeks of each intervention diet
Short-term effects on anthropometric parameters : waist circumference (cm)
Calculated using the average of 3 measures
Measured: Following the 6 weeks of each intervention diet
Short-term effects on blood lipid profiles
Total cholesterol, HDL-chol, and LDL-chol, triglycerides, Apo-B and Apo-A
Measured: Following the 6 weeks of each intervention diet
Short-term effects on body composition (lean and fat mass)
Measured by DEXA (Dual-Energy X-ray Absorptiometry)
Measured: Following the 6 weeks of each intervention diet
Short-term effects on inflammatory parameters
Plasma lipopolysaccharide (LPS), interleukine 6 (IL-6), monocyte chemoattractant protein-1 MCP-1)
Measured: Following the 6 weeks of each intervention diet
Short-term effects on oxidative stress/redox parameters
Total and reduced glutathione
Measured: Following the 6 weeks of each intervention diet
Short-term effects on blood pressure
Systolic and diastolic blood pressure
Measured: Following the 6 weeks of each intervention diet
Short-term effects on liver function
Aminotransferases, alkaline phosphatase, gamma-glutamyl transpeptidase, bilirubin, albumin
Measured: Following the 6 weeks of each intervention diet
Short-term effects on resting metabolic rate
After a 10-hour fast measured by indirect calorimetry
Measured: Following the 6 weeks of each intervention diet
Short-term effects on liver proton density fat fraction by MRS (MRS-PDFF) (%)
Using hepatic fat imagery (MRI)
Measured: Following the 6 weeks of each intervention diet
Short-term effects on mean liver PDFF
Using hepatic fat imagery (MRI)
Measured: Following the 6 weeks of each intervention diet
Short-term effects on total liver volume (mL)
Using hepatic fat imagery (MRI)
Measured: Following the 6 weeks of each intervention diet
Short-term effects on total liver fat index (%.ml)
Using hepatic fat imagery (MRI)
Measured: Following the 6 weeks of each intervention diet
Efficacy of glucagon in correcting hypoglycemia
Time needed to reach a blood glucose > 4 mmol/L after glucagon treatment of an insulin-induced hypoglycemia reaching 4 mmol/L at 15, 20 and 30 min post glucagon administration, peak plasma glucose level two hours after administration, insulin, glucagon, ketone and free fatty acids levels.
Measured: Following the 6 weeks of each intervention diet
Modulation of postprandial glycemic response (Standardized meal-tests)
Hunger, appetite and fullness scores, lat the following times (-20, 0, 15, 30, 60, 90, 120 and 180 min, with 0 min being the start of meal consumption)
Measured: Following the 6 weeks of each intervention diet
Secretion of key gastrointestinal peptides (Standardized meal-tests)
Gastrointestinal peptides : levels of glucose, insulin glucagon, GLP-1, PYY and acylated ghrelin at the following times (-20, 0, 15, 30, 60, 90, 120 and 180 min, with 0 min being the start of meal consumption), as well as their corresponding kinetics including areas under the curve (AUC), peak values and nadirs.
Measured: Following the 6 weeks of each intervention diet
Questionnaire of well-being (score)
Corresponding scores of questionnaire used to assess different quality of life aspects: well-being, fatigue, nausea, hunger, appetite, desire to eat.
Measured: Following the 6 weeks of each intervention diet
Questionnaire of diet satisfaction (score)
Corresponding scores of questionnaire used to assess different quality of life aspects: diet satisfaction, difficulty to follow the diet, difficulty for meal preparation.
Measured: Following the 6 weeks of each intervention diet
Effects on physical activity (steps/day)
Steps per day recorded with a pedometer (PedioRxD) and mobile application (baseline and during each intervention diet)
Measured: Over the 6 weeks of each intervention diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start15 Oct 2019
- Primary completion23 Mar 2020
- Study completion23 Mar 2020
Why it stopped: Lock down due to COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne-Sophie Brazeau, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084418
- Sponsor's protocol ID
- CUT-T1D
- Status last verified
- Feb 2021
- First submitted
- 4 Sep 2019
- Last updated
- 24 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbohydrates Under Target for Type 1 Diabetes Management
- ClinicalTrials.gov ID
- NCT04084418
- Acronym / sponsor ID
- CUT-T1D
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lock down due to COVID-19 pandemic.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 10 Sep 2019 (actual)
- 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.
Recently there has been an increased interest in limiting intake of carbohydrates (CHO) for improving long term health. While healthcare professionals (HCPs) are sometimes reluctant to limit the CHO intake due to the lack of information related to safety issues, low CHO diets are increasing in popularity amongst both people with and without diabetes. One of these diets, the very low CHO high fat diet (VLCHF) raises concern on its impact on the lipid profile, liver, response to glucagon, and insulin dose adjustments when adopting it in the context of type 1 diabetes (T1D). The investigators recently conducted a series of interviews with people with diabetes following a VLCHF diet (Brazeau et al. Manuscript in preparation) to inquire on their reasons for adopting VLCHF as well as challenges they faced. The main reasons to initiate the diet were to limit blood glucose fluctuations and reduce medication. An issue that was frequently mentioned during the interviews was the lack of support from HCPs which often leads to not discussing it with said HCP. This is an important source of concern that can lead to additional safety issues. Our goal is to provide information regarding the safety of a VLCHF diet for T1D and the individualized insulin adjustments required.
The investigators aim to evaluate the changes in daily blood glucose fluctuations after 6 weeks of a VLCHF diet, to monitor the changes in the insulin dosing and to measure impact on lipid profiles, response to glucagon, and liver function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control diet followed by VLCHF diet | Experimental | Other: Control Diet, Other: VLCHF Diet* Phase 1 (1 to 3 weeks): Insulin dose optimization with usual diet * Phase 2 (6 weeks): Control diet (50% of energy from carbohydrates) * Phase 3 (4 weeks): Washout period * Phase 4 (6 weeks): VLCHF diet (10% of energy from carbohydrates) |
| VLCHF diet followed by Control diet | Experimental | Other: Control Diet, Other: VLCHF Diet* Phase 1 (1 to 3 weeks): Insulin dose optimization with usual diet * Phase 2 (6 weeks): VLCHF diet (10% of energy from carbohydrates) * Phase 3 (4 weeks): Washout period * Phase 4 (6 weeks): Control diet (50% of energy from carbohydrates) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Duration of Type 1 Diabetes > 12 months
- On intensive insulin therapy for > 6 months
- Own a smartphone or tablet to use two mobile applications : Keenoa and Piezo: Achieve the Guidelines!
Key exclusion criteria (8 listed)
- Known gastroparesis (clinical diagnosis)
- Advanced kidney disease (eGFR < 50 mL/min)
- Known significant liver disease (e.g., cirrhosis, active hepatitis, liver transplantation)
- Recent (< 6 months) major cardiovascular even (e.g. myocardial infarction, cerebrovascular accident, major revascularization, etc.)
- Pregnancy (ongoing or planned in the next 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 |
|---|---|---|
| Control DietParticipants will be provided with a two-week menu to be consumed 3 times for each intervention, for a total of 6 weeks per intervention. For the Control diet, the diet will provide 50% of energy from CHO, 15% from protein, and 35% from lipids. Menu will be adapted to the participant's food preferences and usual caloric intake by a dietitian. Participants will be asked to limit their alcohol intake in both interventions. During this phase, participants will also have to wear a pedometer and use the Pezio: Achieve the Guidelines! mobile application to help the research assistant track their daily steps remotely. | Other | Control diet followed by VLCHF diet, VLCHF diet followed by Control diet |
| VLCHF DietParticipants will be provided with a two-week menu to be consumed 3 times for each intervention, for a total of 6 weeks per intervention. For the Experimental diet, the diet will provide 10% of energy from CHO, 15% from protein, and 75% from lipids. During the Experimental diet, participants will be provided with a multivitamin to reduce risk of deficiencies due to restrictions on fruits and grain products. Menu will be adapted to the participant's food preferences and usual caloric intake by a dietitian. Participants will be asked to limit their alcohol intake in both interventions. During this phase, participants will also have to wear a pedometer and use the Pezio: Achieve the Guidelines! mobile application to help the research assistant track their daily steps remotely. | Other | Control diet followed by VLCHF diet, VLCHF diet followed by Control diet |
Primary outcome
Daily blood glucose standard deviation
Time frame: Over the 6 weeks of each intervention diet
Using continuous glucose monitoring
27 secondary outcomes
Percentage of time-in-target (range of 4-10 mmol/L)
Time frame: Over the 6 weeks of each intervention diet
Coefficient of glucose variation
Time frame: Over the 6 weeks of each intervention diet
Mean sensor glucose values (mmol/L)
Time frame: Over the 6 weeks of each intervention diet
Glucose area under the curve for 2 hours post-prandial
Time frame: First and last week of each intervention diet
Number of hypoglycemia episodes necessitating treatment recorded
Time frame: Over the 6 weeks of each intervention diet
Percentage of time spent in hypoglycemia ranges (< 4 mmol/L and < 3 mmol/L)
Time frame: Over the 6 weeks of each intervention diet
Percentage of time spent in hyperglycemia ranges (>10 mmol/L and > 15 mmol/L)
Time frame: Over the 6 weeks of each intervention diet
Daily insulin adjustments required to maintain safe blood glucose
Time frame: Over the 6 weeks of each intervention diet
Short-term effects on anthropometric parameters : weight (kg) and height (cm)
Time frame: Following the 6 weeks of each intervention diet
Short-term effects on anthropometric parameters : waist circumference (cm)
Time frame: Following the 6 weeks of each intervention diet
Short-term effects on blood lipid profiles
Time frame: Following the 6 weeks of each intervention diet
Short-term effects on body composition (lean and fat mass)
Time frame: Following the 6 weeks of each intervention diet
Short-term effects on inflammatory parameters
Time frame: Following the 6 weeks of each intervention diet
Short-term effects on oxidative stress/redox parameters
Time frame: Following the 6 weeks of each intervention diet
Short-term effects on blood pressure
Time frame: Following the 6 weeks of each intervention diet
Short-term effects on liver function
Time frame: Following the 6 weeks of each intervention diet
Short-term effects on resting metabolic rate
Time frame: Following the 6 weeks of each intervention diet
Short-term effects on liver proton density fat fraction by MRS (MRS-PDFF) (%)
Time frame: Following the 6 weeks of each intervention diet
Short-term effects on mean liver PDFF
Time frame: Following the 6 weeks of each intervention diet
Short-term effects on total liver volume (mL)
Time frame: Following the 6 weeks of each intervention diet
Short-term effects on total liver fat index (%.ml)
Time frame: Following the 6 weeks of each intervention diet
Efficacy of glucagon in correcting hypoglycemia
Time frame: Following the 6 weeks of each intervention diet
Modulation of postprandial glycemic response (Standardized meal-tests)
Time frame: Following the 6 weeks of each intervention diet
Secretion of key gastrointestinal peptides (Standardized meal-tests)
Time frame: Following the 6 weeks of each intervention diet
Questionnaire of well-being (score)
Time frame: Following the 6 weeks of each intervention diet
Questionnaire of diet satisfaction (score)
Time frame: Following the 6 weeks of each intervention diet
Effects on physical activity (steps/day)
Time frame: Over the 6 weeks of each intervention diet
Results and safety
The study was stopped early (reason given: Lock down due to COVID-19 pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
Related trials for Type 1 Diabetes
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).
Diabetes (Insulin-requiring, Type 1 or Type 2), Pediatric Diabetes
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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 study testing VLCHF Diet in people with Type 1 Diabetes, run by McGill University 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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 24 Feb 2021. 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 was stopped early (reason given: Lock down due to COVID-19 pandemic.). 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?
Daily blood glucose standard deviation (time frame: Over the 6 weeks of each intervention diet). 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 24 Feb 2021.