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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02973867
Other study ID # UF9768
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 22, 2016
Last updated November 24, 2016
Start date November 2016
Est. completion date December 2017

Study information

Verified date November 2016
Source University Hospital, Montpellier
Contact SULTAN ARIANE
Phone 467338402
Email a-sultan@chu-montpellier.fr
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertés
Study type Observational

Clinical Trial Summary

We showed, for the first time, that Z-score increase during obesity was dependent on sex, severity of obesity and age but also on the bone site. Although the increase in BMD at bearing areas seems to be logically explained by the assumption that mechanical stresses have an osteogenic effect on bone tissue, BMD can in no way respond to the concomitant increase in BMD at non-load bearing areas such as the radius. These results suggest that changes in certain systemic compounds, induced by obesity, may interfere with bone metabolism. Moreover, the fact that the BMD or Z score is positively and only correlated with muscle mass and not with fat mass confirm that mechanical stresses are not the only factors acting on bone tissue.

Our objectives are to determine the relationship between plasma concentration of myokines, adipokines, bone markers and BMD in obese subjects.


Description:

We showed, for the first time, that Z-score increase during obesity was dependent on sex, severity of obesity and age but also on the bone site. Although the increase in BMD at bearing areas seems to be logically explained by the assumption that mechanical stresses have an osteogenic effect on bone tissue, BMD can in no way respond to the concomitant increase in BMD at non-load bearing areas such as the radius. (Maïmoun L and Col Bone 2015 Dec 1. S8756-3282 (15) 00421-4). These results suggest that changes in certain systemic compounds, induced by obesity, may interfere with bone metabolism. Moreover, the fact that the BMD or Z score is positively and only correlated with muscle mass and not with fat mass confirm that mechanical stresses are not the only factors acting on bone tissue.

Our objectives are to determine the relationship between plasma concentration of myokines, adipokines, bone markers and BMD in obese subjects.

Our objectives are to determine the relationship between plasma concentration of myokines (myostatin, follistatin), adipokines (leptin, adiponectin) and bone markers (CTX, Trap5, P1NP, ostéocalcin) in a cohort of obese patients, with differents obesity severity, differents ages.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- obese patients age above 18 years old

Exclusion Criteria:

- non agreement of inclusion

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Outcome

Type Measure Description Time frame Safety issue
Primary myosin concentration blood measure 1 day Yes
Secondary adipokines concentration blood measure 1 day No
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