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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03755323
Other study ID # RECHMPL18_0322
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2018
Est. completion date December 31, 2022

Study information

Verified date March 2020
Source University Hospital, Montpellier
Contact Ariane SULTAN, PR
Phone 467338402
Email a-sultan@chu-montpellier.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 5000
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria:

- obese patients age above 18 years old

Exclusion criteria:

- non agreement of inclusion

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

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