Monitoring Patients With Severe Obesity Treated With Wegovy® Using Connected Device: Real-world Data

Not Applicable

Not yet recruiting

• Conditions: Obesity
• Interventions: Device: Withings Body Comp Pro

• Registration Number: NCT06426446
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-05-13
• Study First Submitted QC: 2024-05-17
• Last Update Submitted: 2024-05-17
• Study First Posted: 2024-05-23
• Last Update Posted: 2024-05-23
• Study Start: 2024-06-01
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Man or woman aged over 18 years
• Patients who have reached the maximum dose of their treatment with Wegovy®
• Written consent

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Exclusion Criteria

• Patient on AME (state medical aid)
• Pregnant or breastfeeding woman
• Patient who does not speak French
• Adults under legal protection

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Connected scale	Withings Body Comp Pro	Patients receiving connected scale

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 arterial stiffness measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose	6 months	Arterial stiffness
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
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 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
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 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
The variation of vascular age measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose	6 months	Vascular age
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 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
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

Trial Locations

Locations (1)

Hôpital européen Georges Pompidou - APHP; 🇫🇷 Paris, France