Carbohydrates Under Target for Type 1 Diabetes Management

NCT ID: NCT04084418

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-15
• Study Completion Date: 2020-03-23

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Control Diet

Intervention Type: OTHER

Participants will be provided with a two-week menu to be consumed 3 times for each intervention, for a total of 6 weeks per intervention. For the Control diet, the diet will provide 50% of energy from CHO, 15% from protein, and 35% from lipids. Menu will be adapted to the participant's food preferences and usual caloric intake by a dietitian. Participants will be asked to limit their alcohol intake in both interventions. During this phase, participants will also have to wear a pedometer and use the Pezio: Achieve the Guidelines! mobile application to help the research assistant track their daily steps remotely.

VLCHF Diet

Intervention Type: OTHER

Participants will be provided with a two-week menu to be consumed 3 times for each intervention, for a total of 6 weeks per intervention. For the Experimental diet, the diet will provide 10% of energy from CHO, 15% from protein, and 75% from lipids. During the Experimental diet, participants will be provided with a multivitamin to reduce risk of deficiencies due to restrictions on fruits and grain products. Menu will be adapted to the participant's food preferences and usual caloric intake by a dietitian. Participants will be asked to limit their alcohol intake in both interventions. During this phase, participants will also have to wear a pedometer and use the Pezio: Achieve the Guidelines! mobile application to help the research assistant track their daily steps remotely.

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)

Group Type: EXPERIMENTAL

Control Diet

Intervention Type: OTHER

Participants will be provided with a two-week menu to be consumed 3 times for each intervention, for a total of 6 weeks per intervention. For the Control diet, the diet will provide 50% of energy from CHO, 15% from protein, and 35% from lipids. Menu will be adapted to the participant's food preferences and usual caloric intake by a dietitian. Participants will be asked to limit their alcohol intake in both interventions. During this phase, participants will also have to wear a pedometer and use the Pezio: Achieve the Guidelines! mobile application to help the research assistant track their daily steps remotely.

VLCHF Diet

Intervention Type: OTHER

Participants will be provided with a two-week menu to be consumed 3 times for each intervention, for a total of 6 weeks per intervention. For the Experimental diet, the diet will provide 10% of energy from CHO, 15% from protein, and 75% from lipids. During the Experimental diet, participants will be provided with a multivitamin to reduce risk of deficiencies due to restrictions on fruits and grain products. Menu will be adapted to the participant's food preferences and usual caloric intake by a dietitian. Participants will be asked to limit their alcohol intake in both interventions. During this phase, participants will also have to wear a pedometer and use the Pezio: Achieve the Guidelines! mobile application to help the research assistant track their daily steps remotely.

Interventions

Control Diet

Participants will be provided with a two-week menu to be consumed 3 times for each intervention, for a total of 6 weeks per intervention. For the Control diet, the diet will provide 50% of energy from CHO, 15% from protein, and 35% from lipids. Menu will be adapted to the participant's food preferences and usual caloric intake by a dietitian. Participants will be asked to limit their alcohol intake in both interventions. During this phase, participants will also have to wear a pedometer and use the Pezio: Achieve the Guidelines! mobile application to help the research assistant track their daily steps remotely.

Intervention Type: OTHER

VLCHF Diet

Participants will be provided with a two-week menu to be consumed 3 times for each intervention, for a total of 6 weeks per intervention. For the Experimental diet, the diet will provide 10% of energy from CHO, 15% from protein, and 75% from lipids. During the Experimental diet, participants will be provided with a multivitamin to reduce risk of deficiencies due to restrictions on fruits and grain products. Menu will be adapted to the participant's food preferences and usual caloric intake by a dietitian. Participants will be asked to limit their alcohol intake in both interventions. During this phase, participants will also have to wear a pedometer and use the Pezio: Achieve the Guidelines! mobile application to help the research assistant track their daily steps remotely.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University

OTHER

Sponsor Role: lead

Responsible Party

Anne-Sophie Brazeau

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institut de recherches cliniques de Montréal

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

CUT-T1D

Identifier Type: -

Identifier Source: org_study_id