Carbohydrates Under Target for Type 1 Diabetes Management
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- McGill University
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Daily blood glucose standard deviation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control diet followed by 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)
Intervention: Control Diet (Other)
Control diet followed by 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)
Intervention: VLCHF Diet (Other)
VLCHF diet followed by Control 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)
Intervention: Control Diet (Other)
VLCHF diet followed by Control 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)
Intervention: VLCHF Diet (Other)
Outcomes
Primary Outcomes
Daily blood glucose standard deviation
Time Frame: Over the 6 weeks of each intervention diet
Using continuous glucose monitoring
Secondary Outcomes
- Coefficient of glucose variation(Over the 6 weeks of each intervention diet)
- Short-term effects on mean liver PDFF(Following the 6 weeks of each intervention diet)
- Short-term effects on total liver volume (mL)(Following the 6 weeks of each intervention diet)
- Modulation of postprandial glycemic response (Standardized meal-tests)(Following the 6 weeks of each intervention diet)
- Questionnaire of well-being (score)(Following the 6 weeks of each intervention diet)
- Short-term effects on anthropometric parameters : waist circumference (cm)(Following the 6 weeks of each intervention diet)
- Percentage of time-in-target (range of 4-10 mmol/L)(Over the 6 weeks of each intervention diet)
- Number of hypoglycemia episodes necessitating treatment recorded(Over the 6 weeks of each intervention diet)
- Short-term effects on body composition (lean and fat mass)(Following the 6 weeks of each intervention diet)
- Daily insulin adjustments required to maintain safe blood glucose(Over the 6 weeks of each intervention diet)
- Short-term effects on anthropometric parameters : weight (kg) and height (cm)(Following the 6 weeks of each intervention diet)
- Short-term effects on oxidative stress/redox parameters(Following the 6 weeks of each intervention diet)
- Secretion of key gastrointestinal peptides (Standardized meal-tests)(Following the 6 weeks of each intervention diet)
- Effects on physical activity (steps/day)(Over the 6 weeks of each intervention diet)
- Mean sensor glucose values (mmol/L)(Over the 6 weeks of each intervention diet)
- Glucose area under the curve for 2 hours post-prandial(First and last week of each intervention diet)
- Percentage of time spent in hypoglycemia ranges (< 4 mmol/L and < 3 mmol/L)(Over the 6 weeks of each intervention diet)
- Percentage of time spent in hyperglycemia ranges (>10 mmol/L and > 15 mmol/L)(Over the 6 weeks of each intervention diet)
- Short-term effects on blood lipid profiles(Following the 6 weeks of each intervention diet)
- Short-term effects on inflammatory parameters(Following the 6 weeks of each intervention diet)
- Short-term effects on liver proton density fat fraction by MRS (MRS-PDFF) (%)(Following the 6 weeks of each intervention diet)
- Efficacy of glucagon in correcting hypoglycemia(Following the 6 weeks of each intervention diet)
- Short-term effects on blood pressure(Following the 6 weeks of each intervention diet)
- Short-term effects on liver function(Following the 6 weeks of each intervention diet)
- Short-term effects on resting metabolic rate(Following the 6 weeks of each intervention diet)
- Short-term effects on total liver fat index (%.ml)(Following the 6 weeks of each intervention diet)
- Questionnaire of diet satisfaction (score)(Following the 6 weeks of each intervention diet)
Investigators
Anne-Sophie Brazeau
Assistant Professor
McGill University