Clinical trial NCT04084418: Carbohydrates Under Target for Type 1 Diabetes Management
Official title: Carbohydrates Under Target for Type 1 Diabetes Management
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Daily blood glucose standard deviation
timeFrame: Over the 6 weeks of each intervention diet
Secondary outcomes:
measure: Percentage of time-in-target (range of 4-10 mmol/L)
timeFrame: Over the 6 weeks of each intervention diet
measure: Coefficient of glucose variation
timeFrame: Over the 6 weeks of each intervention diet
measure: Mean sensor glucose values (mmol/L)
timeFrame: Over the 6 weeks of each intervention diet
measure: Glucose area under the curve for 2 hours post-prandial
timeFrame: First and last week of each intervention diet
measure: Number of hypoglycemia episodes necessitating treatment recorded
timeFrame: Over the 6 weeks of each intervention diet
measure: Percentage of time spent in hypoglycemia ranges (< 4 mmol/L and < 3 mmol/L)
timeFrame: Over the 6 weeks of each intervention diet
measure: Percentage of time spent in hyperglycemia ranges (>10 mmol/L and > 15 mmol/L)
timeFrame: Over the 6 weeks of each intervention diet
measure: Daily insulin adjustments required to maintain safe blood glucose
timeFrame: Over the 6 weeks of each intervention diet
measure: Short-term effects on anthropometric parameters : weight (kg) and height (cm)
timeFrame: Following the 6 weeks of each intervention diet
measure: Short-term effects on anthropometric parameters : waist circumference (cm)
timeFrame: Following the 6 weeks of each intervention diet
measure: Short-term effects on blood lipid profiles
timeFrame: Following the 6 weeks of each intervention diet
measure: Short-term effects on body composition (lean and fat mass)
timeFrame: Following the 6 weeks of each intervention diet
measure: Short-term effects on inflammatory parameters
timeFrame: Following the 6 weeks of each intervention diet
measure: Short-term effects on oxidative stress/redox parameters
timeFrame: Following the 6 weeks of each intervention diet
measure: Short-term effects on blood pressure
timeFrame: Following the 6 weeks of each intervention diet
measure: Short-term effects on liver function
timeFrame: Following the 6 weeks of each intervention diet
measure: Short-term effects on resting metabolic rate
timeFrame: Following the 6 weeks of each intervention diet
measure: Short-term effects on liver proton density fat fraction by MRS (MRS-PDFF) (%)
timeFrame: Following the 6 weeks of each intervention diet
measure: Short-term effects on mean liver PDFF
timeFrame: Following the 6 weeks of each intervention diet
measure: Short-term effects on total liver volume (mL)
timeFrame: Following the 6 weeks of each intervention diet
measure: Short-term effects on total liver fat index (%.ml)
timeFrame: Following the 6 weeks of each intervention diet
measure: Efficacy of glucagon in correcting hypoglycemia
timeFrame: Following the 6 weeks of each intervention diet
measure: Modulation of postprandial glycemic response (Standardized meal-tests)
timeFrame: Following the 6 weeks of each intervention diet
measure: Secretion of key gastrointestinal peptides (Standardized meal-tests)
timeFrame: Following the 6 weeks of each intervention diet
measure: Questionnaire of well-being (score)
timeFrame: Following the 6 weeks of each intervention diet
measure: Questionnaire of diet satisfaction (score)
timeFrame: Following the 6 weeks of each intervention diet
measure: Effects on physical activity (steps/day)
timeFrame: Over the 6 weeks of each intervention diet
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Institut de recherches cliniques de Montréal
state: Quebec
Study officials:
References: