NCT04084418

Carbohydrates Under Target for Type 1 Diabetes Management

Terminated NA Last updated 24 February 2021

What this trial tests

NA trial testing Control Diet in Type 1 Diabetes in 8 participants. Terminated before completion.

Timeline

15 October 2019

Primary endpoint
23 March 2020

23 March 2020

Quick facts

Lead sponsor	McGill University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	15 October 2019
Primary completion	23 March 2020
Estimated completion	23 March 2020
Sites	1 location across Canada

Drugs / interventions tested

• Control Diet
• VLCHF Diet

Conditions studied

• Type 1 Diabetes — all drugs for Type 1 Diabetes →

Sponsor

McGill University

Who can join

18 and older, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.