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Carbohydrates Under Target for Type 1 Diabetes Management

Primary Purpose

Type 1 Diabetes

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Control Diet
VLCHF Diet
Sponsored by
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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!

Exclusion Criteria:

  • 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

Sites / Locations

  • Institut de recherches cliniques de Montréal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control diet followed by VLCHF diet

VLCHF diet followed by Control diet

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Daily blood glucose standard deviation
Using continuous glucose monitoring

Secondary Outcome Measures

Percentage of time-in-target (range of 4-10 mmol/L)
Using continuous glucose monitoring
Coefficient of glucose variation
Using continuous glucose monitoring
Mean sensor glucose values (mmol/L)
Using continuous glucose monitoring
Glucose area under the curve for 2 hours post-prandial
Using continuous glucose monitoring
Number of hypoglycemia episodes necessitating treatment recorded
Recorded by participants on hypoglycemia journal
Percentage of time spent in hypoglycemia ranges (< 4 mmol/L and < 3 mmol/L)
Using continuous glucose monitoring
Percentage of time spent in hyperglycemia ranges (>10 mmol/L and > 15 mmol/L)
Using continuous glucose monitoring
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)
Short-term effects on anthropometric parameters : weight (kg) and height (cm)
Weight and height will be combined to report BMI (kg/m^2)
Short-term effects on anthropometric parameters : waist circumference (cm)
Calculated using the average of 3 measures
Short-term effects on blood lipid profiles
Total cholesterol, HDL-chol, and LDL-chol, triglycerides, Apo-B and Apo-A
Short-term effects on body composition (lean and fat mass)
Measured by DEXA (Dual-Energy X-ray Absorptiometry)
Short-term effects on inflammatory parameters
Plasma lipopolysaccharide (LPS), interleukine 6 (IL-6), monocyte chemoattractant protein-1 MCP-1)
Short-term effects on oxidative stress/redox parameters
Total and reduced glutathione
Short-term effects on blood pressure
Systolic and diastolic blood pressure
Short-term effects on liver function
Aminotransferases, alkaline phosphatase, gamma-glutamyl transpeptidase, bilirubin, albumin
Short-term effects on resting metabolic rate
After a 10-hour fast measured by indirect calorimetry
Short-term effects on liver proton density fat fraction by MRS (MRS-PDFF) (%)
Using hepatic fat imagery (MRI)
Short-term effects on mean liver PDFF
Using hepatic fat imagery (MRI)
Short-term effects on total liver volume (mL)
Using hepatic fat imagery (MRI)
Short-term effects on total liver fat index (%.ml)
Using hepatic fat imagery (MRI)
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.
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)
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.
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.
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.
Effects on physical activity (steps/day)
Steps per day recorded with a pedometer (PedioRxD) and mobile application (baseline and during each intervention diet)

Full Information

First Posted
September 4, 2019
Last Updated
February 22, 2021
Sponsor
McGill University
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1. Study Identification

Unique Protocol Identification Number
NCT04084418
Brief Title
Carbohydrates Under Target for Type 1 Diabetes Management
Official Title
Carbohydrates Under Target for Type 1 Diabetes Management
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Lock down due to COVID-19 pandemic.
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
March 23, 2020 (Actual)
Study Completion Date
March 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control diet followed by VLCHF diet
Arm Type
Experimental
Arm Description
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)
Arm Title
VLCHF diet followed by Control diet
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Control Diet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
VLCHF Diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Daily blood glucose standard deviation
Description
Using continuous glucose monitoring
Time Frame
Over the 6 weeks of each intervention diet
Secondary Outcome Measure Information:
Title
Percentage of time-in-target (range of 4-10 mmol/L)
Description
Using continuous glucose monitoring
Time Frame
Over the 6 weeks of each intervention diet
Title
Coefficient of glucose variation
Description
Using continuous glucose monitoring
Time Frame
Over the 6 weeks of each intervention diet
Title
Mean sensor glucose values (mmol/L)
Description
Using continuous glucose monitoring
Time Frame
Over the 6 weeks of each intervention diet
Title
Glucose area under the curve for 2 hours post-prandial
Description
Using continuous glucose monitoring
Time Frame
First and last week of each intervention diet
Title
Number of hypoglycemia episodes necessitating treatment recorded
Description
Recorded by participants on hypoglycemia journal
Time Frame
Over the 6 weeks of each intervention diet
Title
Percentage of time spent in hypoglycemia ranges (< 4 mmol/L and < 3 mmol/L)
Description
Using continuous glucose monitoring
Time Frame
Over the 6 weeks of each intervention diet
Title
Percentage of time spent in hyperglycemia ranges (>10 mmol/L and > 15 mmol/L)
Description
Using continuous glucose monitoring
Time Frame
Over the 6 weeks of each intervention diet
Title
Daily insulin adjustments required to maintain safe blood glucose
Description
Adjustments (basal and prandial) to avoid hypoglycemia (blood glucose < 4 mmol/L) and hyperglycemia (blood glucose > 15 mmol/L)
Time Frame
Over the 6 weeks of each intervention diet
Title
Short-term effects on anthropometric parameters : weight (kg) and height (cm)
Description
Weight and height will be combined to report BMI (kg/m^2)
Time Frame
Following the 6 weeks of each intervention diet
Title
Short-term effects on anthropometric parameters : waist circumference (cm)
Description
Calculated using the average of 3 measures
Time Frame
Following the 6 weeks of each intervention diet
Title
Short-term effects on blood lipid profiles
Description
Total cholesterol, HDL-chol, and LDL-chol, triglycerides, Apo-B and Apo-A
Time Frame
Following the 6 weeks of each intervention diet
Title
Short-term effects on body composition (lean and fat mass)
Description
Measured by DEXA (Dual-Energy X-ray Absorptiometry)
Time Frame
Following the 6 weeks of each intervention diet
Title
Short-term effects on inflammatory parameters
Description
Plasma lipopolysaccharide (LPS), interleukine 6 (IL-6), monocyte chemoattractant protein-1 MCP-1)
Time Frame
Following the 6 weeks of each intervention diet
Title
Short-term effects on oxidative stress/redox parameters
Description
Total and reduced glutathione
Time Frame
Following the 6 weeks of each intervention diet
Title
Short-term effects on blood pressure
Description
Systolic and diastolic blood pressure
Time Frame
Following the 6 weeks of each intervention diet
Title
Short-term effects on liver function
Description
Aminotransferases, alkaline phosphatase, gamma-glutamyl transpeptidase, bilirubin, albumin
Time Frame
Following the 6 weeks of each intervention diet
Title
Short-term effects on resting metabolic rate
Description
After a 10-hour fast measured by indirect calorimetry
Time Frame
Following the 6 weeks of each intervention diet
Title
Short-term effects on liver proton density fat fraction by MRS (MRS-PDFF) (%)
Description
Using hepatic fat imagery (MRI)
Time Frame
Following the 6 weeks of each intervention diet
Title
Short-term effects on mean liver PDFF
Description
Using hepatic fat imagery (MRI)
Time Frame
Following the 6 weeks of each intervention diet
Title
Short-term effects on total liver volume (mL)
Description
Using hepatic fat imagery (MRI)
Time Frame
Following the 6 weeks of each intervention diet
Title
Short-term effects on total liver fat index (%.ml)
Description
Using hepatic fat imagery (MRI)
Time Frame
Following the 6 weeks of each intervention diet
Title
Efficacy of glucagon in correcting hypoglycemia
Description
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.
Time Frame
Following the 6 weeks of each intervention diet
Title
Modulation of postprandial glycemic response (Standardized meal-tests)
Description
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)
Time Frame
Following the 6 weeks of each intervention diet
Title
Secretion of key gastrointestinal peptides (Standardized meal-tests)
Description
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.
Time Frame
Following the 6 weeks of each intervention diet
Title
Questionnaire of well-being (score)
Description
Corresponding scores of questionnaire used to assess different quality of life aspects: well-being, fatigue, nausea, hunger, appetite, desire to eat.
Time Frame
Following the 6 weeks of each intervention diet
Title
Questionnaire of diet satisfaction (score)
Description
Corresponding scores of questionnaire used to assess different quality of life aspects: diet satisfaction, difficulty to follow the diet, difficulty for meal preparation.
Time Frame
Following the 6 weeks of each intervention diet
Title
Effects on physical activity (steps/day)
Description
Steps per day recorded with a pedometer (PedioRxD) and mobile application (baseline and during each intervention diet)
Time Frame
Over the 6 weeks of each intervention diet

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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! Exclusion Criteria: 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
Facility Information:
Facility Name
Institut de recherches cliniques de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2W1R7
Country
Canada

12. IPD Sharing Statement

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Carbohydrates Under Target for Type 1 Diabetes Management

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