Carbohydrates Under Target for Type 1 Diabetes Management

Status Withdrawn

Clinical Trial Summary

Recently, there has been an increased interest in limiting carbohydrates (CHO) intakes for improving long-term health. Low CHO (<30% energy from CHO) and very low CHO high fat (VLCHF; 10% CHO, 75% Lipid) diets are being advocated among people living with diabetes given their almost immediate favorable impact on post-prandial blood glucose levels and on hemoglobin A1c that have been reported by users. Adoption of these diets are met with reluctance by healthcare professionals due to the lack of information on their safety. Concerns include the impact on hypoglycemia frequency and glucagon response to hypoglycemia, diabetic ketoacidosis, lipid profile, liver function insulin dose adjustments when adopting them in the context of type 1 diabetes (T1D). Through a series of interviews, people with diabetes following a VLCHF reported that the lack of support from HCPs often leads to hiding the fact that they have adopted a VLCHF diet. This is an important source of concern that can lead to additional safety issues. The goal is to fill an important knowledge gap about the effectiveness, benefits and risks of low CHO and VLCHF diets for people with T1D. The primary objective is to compare the percentage of TIR of adults with T1D following a low-CHO diet or a VLCHF diet versus a control diet for 12 weeks. The secondary objectives are (1) to evaluate efficacy of glucagon in correcting hypoglycemia in the context of restricted carbohydrates intakes; (2) to evaluate changes in HbA1c at 12 weeks and glucose fluctuations and % of time in hypoglycemia at 6 weeks and 12 weeks of control diet, low-CHO diet or VLCHF diet; (3) to compare key cardiometabolic risk factors (body composition, blood lipids, blood pressure and liver inflammatory markers and function) at 6 weeks and 12 weeks of control diet, low-CHO diet or VLCHF diet; (4) to evaluate the effect of restrictive CHO diets (low-CHO and VLCHF) on the composition of the intestinal microbiota (optional).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04758858
Study type	Interventional
Source	Institut de Recherches Cliniques de Montreal
Contact
Status	Withdrawn
Phase	N/A
Start date	March 2021
Completion date	March 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05653518` - Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes	N/A
Enrolling by invitation	`NCT05515939` - Evaluating the InPen in Pediatric Type 1 Diabetes
Completed	`NCT05109520` - Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
Recruiting	`NCT04016987` - Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes	N/A
Active, not recruiting	`NCT04190368` - Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes	N/A
Active, not recruiting	`NCT05413005` - Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus	Early Phase 1
Active, not recruiting	`NCT04668612` - Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes	N/A
Recruiting	`NCT05414409` - The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action	Phase 2
Completed	`NCT02837094` - Enhanced Epidermal Antigen Specific Immunotherapy Trial -1	Phase 1
Recruiting	`NCT05670366` - The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes	N/A
Recruiting	`NCT05418699` - Real-life Data From Diabetic Patients on Closed-loop Pumps
Completed	`NCT04084171` - Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6	N/A
Recruiting	`NCT06144554` - Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
Recruiting	`NCT05379686` - Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes	N/A
Recruiting	`NCT05153070` - Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes	Phase 2
Recruiting	`NCT05281614` - Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D	Early Phase 1
Withdrawn	`NCT04259775` - Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes	N/A
Active, not recruiting	`NCT01600924` - Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
Completed	`NCT02750527` - Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany
Completed	`NCT02914886` - Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS)	Phase 4