Intensive Lifestyle Intervention in Patients With Insulin-treated Type 2 Diabetes: a Pilot Project

NCT04957173 | Withdrawn

• 1 other identifier: ILIAD-CHUM
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a pilot study carried out to assess the feasibility, safety and effectiveness of an intensive lifestyle intervention, implemented virtually by a multidisciplinary team, in patients living with advanced insulin-treated T2DM. This 24-week study will include 2 pre-intervention virtual visits and 15 virtual visits during the intervention.

Conditions

Type 2 Diabetes Treated With Insulin

Outcome Measures

Primary Outcomes (1)

• The primary outcome of this study will be weight loss in the participants.

  Weeks 1 to 4: Target weight loss of 1% per week (on average) Weeks 5 to 8: Loss of 0.5% of target weight per week (on average) Weeks 9 to 24: Maintaining target weight

  24 weeks

Study Arms (1)

Intensive lifestyle intervention

OTHER

Participants will undergo an intensive lifestyle intervention, implemented virtually by a medical team with expertise in the management of T2DM. This team will be made up of an endocrinologist, a nutritionist and a nurse.

Other: Lifestyle intervention

Interventions

Lifestyle intervention OTHER

The intervention includes a total of 17 virtual meetings and aims to achieve a weight loss of 0.8 to 1% of the initial weight per week. This will include 3 successive phases: 1. A significant calorie restriction (A minimum deficit of 800 kcal / day of their daily energy expenditure) for a period of 4 weeks; 2. A moderate calorie restriction (minimum deficit of 500 kcal / day of their daily energy expenditure) for a period of 4 weeks; 3. A maintenance phase of weight loss for 16 weeks. 4. An optional phase of monthly follow-ups for a period of 3 months (no intervention)

Intensive lifestyle intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 75, BMI 27 to 45 kg / m2
• Diagnosed T2DM
• Insulin-treated for a minimum of 5 years
• Having a glycated hemoglobin \<9.5% (HbA1c dating ≤3 months)
• Having internet and telephone access to enable monitoring of the intervention and remote blood glucose monitoring
• If treated with a glucagon like peptide-1 (GLP-1), must be on a stable dose for a minimum of 6 months
• Having good autonomy in managing medication (including insulin) and preparing meals.

You may not qualify if:

• A diagnosis of T2DM with a tendency to ketosis
• A history of ketoacidosis associated with taking an SGLT2 inhibitor
• Medical history of eating disorders
• Severe hypoglycemia in the past year or decreased perception of hypoglycemia determined by Clarke's method with a score ≥ 4 (17)
• Daily fluid restriction
• A pregnant / breastfeeding participant, wishing to be pregnant during the study period or having given birth less than one year before the start of the study
• The presence of advanced complications of T2DM (renal failure with estimated glomerular filtration rate \<30 ml / min / 1.73m2, proliferative diabetic retinopathy, severe neuropathy)
• Drug or alcohol use in the past 12 months. Defined by more than 2 drinks per day or more 10 per week for women, and more than 3 drinks per day or more than 15 per week for men.
• Advanced fragility (See the score which is in the recommendations of Diabetes Canada chapter elderly people)
• A macrovascular episode (heart attack, stenting, coronary bypass surgery or stroke less than 6 months ago.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Institut de Recherches Cliniques de Montreal: collaborator
• CHU de Quebec-Universite Laval: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 12, 2021
• Study Start: October 14, 2021
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: September 5, 2023

Record last verified: 2023-08