Monitoring Patients With Severe Obesity Treated With Wegovy® Using Connected Device: Real-world Data
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- The relative difference in weight loss achieved at 6 months of treatment at the maximum tolerated dose ((weight after 6 months of treatment at the maximum tolerated dose - baseline weight) / baseline weight)
Study Overview
Brief Summary
This study involves collecting real-world data on body weight, body composition, cardiovascular parameters, and neurovegetative parameters using a connected scale in patients with severe obesity treated with Wegovy®.
Detailed Description
Obesity is a chronic disease associated with numerous co-morbidities. New treatments for obesity, notably GLP-1 (Glucagon-like peptide 1) analogs, have led to promising advances. Semaglutide 2.4 mg weekly subcutaneous injection, marketed under the brand name Wegovy®, was recently approved in France for weight loss in patients with severe obesity and at least one comorbidity. Several real-world studies have confirmed the effectiveness of semaglutide in reducing body weight and HbA1c. However, few studies have evaluated the kinetics and interindividual variability of changes in body weight and composition as well as cardiovascular health. There appears to be a need for a comprehensive real-world assessment of patients living with severe obesity receiving Wegovy®.
The TELE-SEMA project involves collecting real-world data on body weight, body composition, cardiovascular and neurovegetative parameters via connected scales in patients with severe obesity treated with Wegovy®.
The main objectives will be to assess inter-individual weight variability and explore the determinants that may influence weight loss, body composition and possible eating disorders.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Man or woman aged over 18 years
- •Patients who have reached the maximum dose of their treatment with Wegovy®
- •Written consent
Exclusion Criteria
- •Patient on AME (state medical aid)
- •Pregnant or breastfeeding woman
- •Patient who does not speak French
- •Adults under legal protection
Outcomes
Primary Outcomes
The relative difference in weight loss achieved at 6 months of treatment at the maximum tolerated dose ((weight after 6 months of treatment at the maximum tolerated dose - baseline weight) / baseline weight)
Time Frame: 6 months
Body weight measured at month 0 and 6
Secondary Outcomes
- The variation of heart rate measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose(6 months)
- The variation of nervous system health (electrochemical skin conductance) measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose(6 months)
- The variation of arterial stiffness measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose(6 months)
- The variation of body weight measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose(6 months)
- The variation of pulse wave velocity measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose(6 months)
- The variation of body composition (fat mass, muscle mass, and bone mass) measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose(6 months)
- Difference in mean arterial stiffness before and after 6 months of treatment with semaglutide at the maximum tolerated dose(6 months)
- Difference in mean vascular age before and after 6 months of treatment with semaglutide at the maximum tolerated dose(6 months)
- Difference in the level of physical activity assessed by the IPAQ short version questionnaire before and after 6 months of treatment with semaglutide at the maximum tolerated dose(6 months)
- The variation of vascular age measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose(6 months)
- Difference in mean heart rate before and after 6 months of treatment with semaglutide at the maximum tolerated dose(6 months)
- Difference in eating behavior assessed by the BES questionnaire before and after 6 months of treatment with semaglutide at the maximum tolerated dose(6 months)
- Difference in mean pulse wave velocity before and after 6 months of treatment with semaglutide at the maximum tolerated dose(6 months)
- Percentage of missed doses compared to the total number of prescribed doses after 6 months of treatment at the maximum tolerated dose(6 months)