Obesity
Conditions
Keywords
Obesity, Wegovy, Semaglutide 2.4 mg/week
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.
Interventions
DEVICEWithings Body Comp Pro
Withings Body Comp Pro from which the following features will be used: body weight, body composition (fat, muscle and bone mass, cardiovascular health (pulse wave velocity, arterial stiffness, vascular age, standing heart rate), nervous health (electrochemical skin conductance)
Sponsors
BPIfrance
Withings
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 6 months | Body weight measured at month 0 and 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Body composition measured weekly |
| The variation of pulse wave velocity measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose | 6 months | Pulse wave velocity |
| The variation of arterial stiffness measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose | 6 months | Arterial stiffness |
| The variation of vascular age measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose | 6 months | Vascular age |
| The variation of heart rate measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose | 6 months | Heart rate |
| 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 | Nervous system health measured weekly |
| The variation of body weight measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose | 6 months | Body weight measured weekly |
| Difference in mean arterial stiffness before and after 6 months of treatment with semaglutide at the maximum tolerated dose | 6 months | Arterial stiffness at month 0 and 6 |
| Difference in mean vascular age before and after 6 months of treatment with semaglutide at the maximum tolerated dose | 6 months | Vascular age at month 0 and 6 |
| Difference in mean heart rate before and after 6 months of treatment with semaglutide at the maximum tolerated dose | 6 months | Heart rate at month 0 and 6 |
| 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 | Eating behavior at month 0 and 6 |
| 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 | Level of physical activity at month 0 and 6 |
| Percentage of missed doses compared to the total number of prescribed doses after 6 months of treatment at the maximum tolerated dose | 6 months | missed doses compared to the total number of prescribed doses at month 6 |
| Difference in mean pulse wave velocity before and after 6 months of treatment with semaglutide at the maximum tolerated dose | 6 months | Pulse wave velocity at month 0 and 6 |
Countries
France
Contacts
Primary ContactJosephine BRAUN
Backup ContactLiliane HAMMANI-BERKANI
Outcome results
None listed