Establishment of a Database of Patients Suffering From Obesity With a Medical Treatment (Elodie Cohort)

Establishment of a Database of Patients Suffering From Obesity With a Medical Treatment in the Framework of The Specialized Obesity Center Languedoc-Roussillon CHU Montpellier

Obesity is a public health problem, given its prevalence (15% in France in 2012, Obépi survey) but also by the complications that it generates. We were firstly, intersted in bone mineral density during obesity.

We were able to confirm in an observational study that BMD (Z-score)was augmented. We also showed, for the first time, that this increase in Z-score was dependent on sex, severity of obesity and age but also bone site. If the increase in BMD at the level of the bearing zones seems logically to be explained by the hypothesis that the mechanical stresses have an osteogenic effect on the bone tissue, the latter can not in any way respond to the concomitant increase in BMD at non-bearing areas such as the radius.These results suggest that changes in certain systemic compounds induced by obesity may interfere with bone metabolism. recent data also suggest a change in the concentration of pro-glucagon peptides (GLP-1, glicentin, glucagon, etc.) in obese subjects and in bariatric surgery). Although body composition and its variation after surgery could be largely involved in the modification of these peptides, no data on these potential relationships is currently available. However, no data are available for baseline body composition and weight loss data. Finally, 80% of obesity is associated with insulin resistance, a key mechanism in the pathophysiology of type 2 diabetes. A metabolically healthy obesity phenotype is described, although the definition criteria are not consensual.The evolution of this phenotype with aging and with the duration of evolution of obesity is not well described.

Our goal is to create a database of weight-bearing patients in the care setting and to determine the "hormonal dialogue" between peripheral (muscular and adipose) and bone tissues, which may be associated with changes in body composition during obesity and aging, and that according to sex.

Study Overview

• Status: Unknown
• Conditions: BMI Greater Than 30

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • Uhmontpellier
    • Contact: Ariane SULTAN, PR; Phone Number: 33 467338402; Email: a-sultan@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects older than 18 years (BMI greater than 30). These patients are seen in consultation with a request for weight management carried out in the cade care , in the framework of The Specialized Obesity Center Languedoc-Roussillon CHU Montpellier

Description

Inclusion criteria:

- obese patients age above 18 years old

Exclusion criteria:

- non agreement of inclusion

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
identify the determinants of body composition	Compile a comprehensive database of all patients who are weight-bearing as part of the care to identify the determinants of body composition (lean mass, bone mass, muscle mass) in the obese subject according to sex and age, and the link with the complications of obesity.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measured plasma concentration	Measured plasma concentration of myokines, adipokines, markers of bone remodeling, incretin-glucagon	1 day
measurement of muscle strength	the measurement of muscle strength by hand-grip and performance by 6-minute walk test.	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Ariane SULTAN, PR, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: November 26, 2018
• First Submitted That Met QC Criteria: November 26, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Obesity; Nutrition Disorders
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: RECHMPL18_0322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No