Intensive Lifestyle Intervention in Patients With Insulin-treated Type 2 Diabetes: a Pilot Project
- Conditions
- Type 2 Diabetes Treated With Insulin
- Interventions
- Other: Lifestyle intervention
- Registration Number
- NCT04957173
- Lead Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intensive lifestyle intervention 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.
- Primary Outcome Measures
Name Time Method The primary outcome of this study will be weight loss in the participants. 24 weeks 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
Name Time Method