Other Clinical Trial - Intensive Lifestyle Intervention in Patients With

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Diabetes Mellitus, Type 2
Type 2 Diabetes Treated With Insulin

Clinical Trial Details

NCT number	NCT04957173
Study type	Interventional
Source	Centre hospitalier de l'Université de Montréal (CHUM)
Contact
Status	Withdrawn
Phase	N/A
Start date	October 14, 2021
Completion date	July 30, 2023

View Details

See also
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Completed	`NCT02060916` - Study to Evaluate the Safety and Efficacy of PAZ320 in Patients With Type 2 Diabetes	Phase 2
Active, not recruiting	`NCT05785832` - A Randomized Trial Evaluating Control-IQ Technology in Adults With Type 2 Diabetes	N/A
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms