Carbohydrates Under Target for Type 1 Diabetes Management

NCT04084418 | Terminated

• 1 other identifier: CUT-T1D
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Daily blood glucose standard deviation

  Using continuous glucose monitoring

  Over the 6 weeks of each intervention diet

Secondary Outcomes (27)

• Percentage of time-in-target (range of 4-10 mmol/L)

  Over the 6 weeks of each intervention diet

• Coefficient of glucose variation

  Over the 6 weeks of each intervention diet

• Mean sensor glucose values (mmol/L)

  Over the 6 weeks of each intervention diet

• Glucose area under the curve for 2 hours post-prandial

  First and last week of each intervention diet

• Number of hypoglycemia episodes necessitating treatment recorded

  Over the 6 weeks of each intervention diet

Study Arms (2)

Control diet followed by VLCHF diet

EXPERIMENTAL

* 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)

Other: Control Diet; Other: VLCHF Diet

VLCHF diet followed by Control diet

EXPERIMENTAL

* 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)

Other: Control Diet; Other: VLCHF Diet

Interventions

Control Diet 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.

Control diet followed by VLCHF diet; VLCHF diet followed by Control diet

VLCHF Diet 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.

Control diet followed by VLCHF diet; VLCHF diet followed by Control diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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!

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W1R7, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 10, 2019
• Study Start: October 15, 2019
• Primary Completion: March 23, 2020
• Study Completion: March 23, 2020
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

CA (1)