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

May 17, 2024 updated by: Assistance Publique - Hôpitaux de Paris
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®.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Connected scale
Patients receiving connected scale
Device: Withings 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The variation of body weight measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose
Time Frame: 6 months
Body weight measured weekly
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
Time Frame: 6 months
Body composition measured weekly
6 months
The variation of pulse wave velocity measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose
Time Frame: 6 months
Pulse wave velocity
6 months
The variation of arterial stiffness measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose
Time Frame: 6 months
Arterial stiffness
6 months
The variation of vascular age measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose
Time Frame: 6 months
Vascular age
6 months
The variation of heart rate measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose
Time Frame: 6 months
Heart rate
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
Time Frame: 6 months
Nervous system health measured weekly
6 months
Difference in mean pulse wave velocity before and after 6 months of treatment with semaglutide at the maximum tolerated dose
Time Frame: 6 months
Pulse wave velocity at month 0 and 6
6 months
Difference in mean arterial stiffness before and after 6 months of treatment with semaglutide at the maximum tolerated dose
Time Frame: 6 months
Arterial stiffness at month 0 and 6
6 months
Difference in mean vascular age before and after 6 months of treatment with semaglutide at the maximum tolerated dose
Time Frame: 6 months
Vascular age at month 0 and 6
6 months
Difference in mean heart rate before and after 6 months of treatment with semaglutide at the maximum tolerated dose
Time Frame: 6 months
Heart rate at month 0 and 6
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
Time Frame: 6 months
Eating behavior at month 0 and 6
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
Time Frame: 6 months
Level of physical activity at month 0 and 6
6 months
Percentage of missed doses compared to the total number of prescribed doses after 6 months of treatment at the maximum tolerated dose
Time Frame: 6 months
missed doses compared to the total number of prescribed doses at month 6
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

BPIfrance
Withings

Investigators

  • Principal Investigator: Sébastien Czernichow, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

May 13, 2024

First Submitted That Met QC Criteria

May 17, 2024

First Posted (Actual)

May 23, 2024

Study Record Updates

Last Update Posted (Actual)

May 23, 2024

Last Update Submitted That Met QC Criteria

May 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP230587

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

IPD Sharing Time Frame

Two years after the last publication

IPD Sharing Access Criteria

Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision.

Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization.

Processing of shared data must comply with European General Data Protection Regulation (GDPR)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Withings Body Comp Pro

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe