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

Intervention Intensive Sur le Mode de Vie Chez Les Patients Atteints d'obésité Avec un diabète de Type 2 avancé Insuline-traité : un Projet Pilote

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.

Study Overview

• Status: Withdrawn
• Conditions: Type 2 Diabetes Treated With Insulin
• Intervention / Treatment: Other: Lifestyle intervention

Detailed Description

The prevalence of type 2 diabetes (T2DM) has increased rapidly over the past decades. This chronic condition, strongly associated with abdominal obesity, leads to serious complications. Traditional recommendations for the management of T2DM mainly suggest the use of drugs to control blood sugar and the concomitant risk factors. However, this approach can be expensive and some therapies have significant side effects. Although programs aimed at improving lifestyle habits are essential in the management of T2DM, the implementation of these programs involves many challenges such as the need for patients to travel and access to a multidisciplinary team.

A few studies have recently proposed that one can induce remission of T2DM. Considering that this disease appears to be the result of metabolic stress induced by an excessive accumulation of fat in the internal organs, the reduction of this excess of lipids by a significant weight loss could reduce the metabolic stress and modify the progression of the disease. disease.

The implementation of a virtual lifestyle intervention could make it possible to follow up patients who do not have access to a multidisciplinary team nearby or who are unable to travel.

The objective of this project is to assess the feasibility of the nutritional intervention by measuring food intake, eating behaviors and factors facilitating or limiting adherence to the intervention. As well as to examine the effect of this intervention on weight loss and waist circumference; doses of insulin and other drugs to treat T2DM, dyslipidemia and high blood pressure; glycemic control and possible complications; eating behaviors and quality of life.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danijela Bovan; Phone Number: 514 987 5617; Email: danijela.bovan@ircm.qc.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2W 1R7
      • Recruiting
      • Institut de Recherches Cliniques de Montreal
      • Contact: Danijela Bovan; Phone Number: 514 987 5617; Email: danijela.bovan@ircm.qc.ca
      • Contact: Élisabeth Nguyen; Phone Number: 3318 514 987 5500; Email: elisabeth.nguyen@ircm.qc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

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

Exclusion criteria:

1. A diagnosis of T2DM with a tendency to ketosis
2. A history of ketoacidosis associated with taking an SGLT2 inhibitor
3. Medical history of eating disorders
4. Severe hypoglycemia in the past year or decreased perception of hypoglycemia determined by Clarke's method with a score ≥ 4 (17)
5. A history of gastrointestinal tract surgery that alters the ability to absorb nutrients (weight loss surgery, short bowel, etc.) [cholecystectomy or appendectomy are not exclusion criteria]
6. A history of pancreatic insufficiency, advanced liver disease or liver transplant [Hepatic steatosis is not an exclusion criterion]
7. Active cancer under treatment or a history of cancer with active treatment in the past year (basal cell carcinoma is not an exclusion criteria)
8. Daily fluid restriction
9. 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
10. The presence of advanced complications of T2DM (renal failure with estimated glomerular filtration rate <30 ml / min / 1.73m2, proliferative diabetic retinopathy, severe neuropathy)
11. 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.
12. Advanced fragility (See the score which is in the recommendations of Diabetes Canada chapter elderly people)
13. A macrovascular episode (heart attack, stenting, coronary bypass surgery or stroke less than 6 months ago.
14. An active wound Additional to the inclusion/exclusion criterias, the PI will determine the inclusion of the participant to the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Intensive lifestyle intervention; 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; 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: A significant calorie restriction (A minimum deficit of 800 kcal / day of their daily energy expenditure) for a period of 4 weeks;; A moderate calorie restriction (minimum deficit of 500 kcal / day of their daily energy expenditure) for a period of 4 weeks;; A maintenance phase of weight loss for 16 weeks.; An optional phase of monthly follow-ups for a period of 3 months (no intervention)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2021
• Primary Completion (Actual): July 30, 2023
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: June 30, 2021
• First Posted (Actual): July 12, 2021

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: ILIAD-CHUM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No