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

NCT04957173 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-09-05

No results posted yet for this study

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

Interventions

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: 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)

Sponsors & Collaborators

  • Institut de Recherches Cliniques de Montreal

    collaborator OTHER

  • CHU de Quebec-Universite Laval

    collaborator OTHER

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-14
Primary Completion
2023-07-30
Completion
2023-07-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04957173 on ClinicalTrials.gov