Back to resultsIntensive Lifestyle Intervention in Patients With Insulin-treated Type 2 Diabetes: a Pilot Project (ILIAD)
Primary Purpose
Type 2 Diabetes Treated With Insulin
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lifestyle intervention
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Treated With Insulin
Eligibility Criteria
Inclusion criteria:
- 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.
Exclusion criteria:
- 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)
- 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]
- A history of pancreatic insufficiency, advanced liver disease or liver transplant [Hepatic steatosis is not an exclusion criterion]
- Active cancer under treatment or a history of cancer with active treatment in the past year (basal cell carcinoma is not an exclusion criteria)
- 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.
- An active wound Additional to the inclusion/exclusion criterias, the PI will determine the inclusion of the participant to the study.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intensive lifestyle intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04957173
First Posted
June 23, 2021
Last Updated
August 30, 2023
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Institut de Recherches Cliniques de Montreal, CHU de Quebec-Universite Laval
1. Study Identification
Unique Protocol Identification Number
NCT04957173
Brief Title
Intensive Lifestyle Intervention in Patients With Insulin-treated Type 2 Diabetes: a Pilot Project
Acronym
ILIAD
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Recruitment was difficult, and the investigator decided to close the study.
Study Start Date
October 14, 2021 (Actual)
Primary Completion Date
July 30, 2023 (Actual)
Study Completion Date
July 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Institut de Recherches Cliniques de Montreal, CHU de Quebec-Universite Laval
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Treated With Insulin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intensive lifestyle intervention
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Lifestyle intervention
Intervention Description
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)
Primary Outcome Measure Information:
Title
The primary outcome of this study will be weight loss in the participants.
Description
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
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
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.
Exclusion criteria:
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)
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]
A history of pancreatic insufficiency, advanced liver disease or liver transplant [Hepatic steatosis is not an exclusion criterion]
Active cancer under treatment or a history of cancer with active treatment in the past year (basal cell carcinoma is not an exclusion criteria)
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.
An active wound Additional to the inclusion/exclusion criterias, the PI will determine the inclusion of the participant to the study.
12. IPD Sharing Statement
Learn more about this trial
Intensive Lifestyle Intervention in Patients With Insulin-treated Type 2 Diabetes: a Pilot Project
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