Brief 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).

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Timeline

Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2 years study duration

First Submitted

Initial submission to the registry

February 10, 2021

Completed

7 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed

12 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed

Last Updated

July 13, 2021

Status Verified

July 1, 2021

Enrollment Period

2 years

First QC Date

February 10, 2021

Last Update Submit

July 7, 2021

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

Percentage of time-in-target (range of 4-10 mmol/L)
Using continuous glucose monitoring (FreeStyle Libre)
From enrollment to end of study, total of 14 weeks

Secondary Outcomes (63)

Time to resolve an induced hypoglycemia (>4 mmol/L)
After administration of subcutaneous insulin; At beginning (week 3) and end (week 14) of the diet intervention, each test lasts approximately 5 hours
Peak plasma glucose level two hours after glucagon administration
After administration of glucagon; At beginning (week 3) and end (week 14) of the diet intervention, each test lasts approximately 5 hours
Glycated hemoglobin (HbA1c)
During blood test : At baseline (day 1), before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14)
Fructosamine
During blood test : At baseline (day 1), before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14)
Fasting blood glucose
From beginning (week 3) to end (week 14) of diet intervention
+58 more secondary outcomes

Study Arms (3)

VLCHF (Very Low CHO High Fat) Diet

ACTIVE COMPARATOR

10% of energy from CHO, 15% proteins, and 75% lipids

Other: Insulin treatment optimization with participant's usual dietDevice: Abbott's FreeStyle LibreOther: Three-day food journalOther: Medical visitOther: Blood pressure measurementsOther: Anthropometric parameters measurementsOther: Indirect calorimetry testOther: Well-being questionnaireOther: Diet appreciation questionnaireDevice: Pedometer (PiezoRxD)Other: Hepatic imaging (MRI)Other: Glucagon efficiency testOther: Body composition : Dual Energy X-ray absorptiometry (DEXA)Other: Blood testsOther: Stool sample collections (optional)Other: Hypoglycemia journalOther: Ketone journalOther: Adherence to the diet (Keenoa)

Low-CHO Diet

ACTIVE COMPARATOR

30% of energy from CHO, 15% proteins and 55% lipids

Control Diet

PLACEBO COMPARATOR

50% of energy from CHO, 15% proteins and 35% lipids

Interventions

Insulin treatment optimization with participant's usual dietOTHER

Two weeks before the intervention phase, insulin dose optimization and revision of participants' knowledge on carbohydrates counting, hypo- and hyperglycemia prevention and treatment will be done with a nurse and a dietitian under a physician's supervision. Once to twice a week, participants will be contacted to review if glucose values are in target.