Ghrelin Resistance in Adolescents With Idiopathic Scoliosis

NCT ID: NCT02829476

Last Updated: 2017-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-07-31

Brief Summary

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Adolescent idiopathic Scoliosis (AIS) is the most common spine pathology. It is opposed to secondary scoliosis due to chronic diseases. Many hypotheses have been made to elucidate the origin of this illness. Recently, the melatonin pathway has been investigated as pinealectomy of the chicken creates a scoliosis that resembles AIS and melatonin supplementation reverses the process. In addition administration of melatonin to AIS patients improved the pathology. However this hypothesis has shown controversial results. Recent studies have demonstrated melatonin cellular resistance in osteoblastic cells from AIS patients. Melatonin acts through G protein coupled receptor (GPCR), mainly using the Gi pathway. In AIS osteoblasts, this pathway is blocked leading to a decrease in the inactivation of the adenylyl cyclase and therefore maintenance of high level of cyclic adenosine monophosphate (cAMP) concentrations in the cells. As modulation of cAMP is important for osteogenesis such resistance may be critical for the initiation or the development of AIS.

Gi signalization is used by several other GPCR, thus, this hormonal resistance could logically be found in other hormonal or mediator pathways. A precedent study previously focused on ghrelin in AIS, and demonstrated that AIS patients possess elevated plasmatic values of ghrelin. This study also observed decreased response to ghrelin in AIS cultures osteoblasts.

Detailed Description

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Conditions

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Scoliosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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patients with AIS

Patients will have 'Osteoblast sample'

Group Type EXPERIMENTAL

Osteoblast sample

Intervention Type BIOLOGICAL

culture osteoblasts obtained from vertebrae fragments from 30 patients with AIS and from 10 control patients with secondary scoliosis

control patients

Group Type EXPERIMENTAL

Osteoblast sample

Intervention Type BIOLOGICAL

culture osteoblasts obtained from vertebrae fragments from 30 patients with AIS and from 10 control patients with secondary scoliosis

Interventions

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Osteoblast sample

culture osteoblasts obtained from vertebrae fragments from 30 patients with AIS and from 10 control patients with secondary scoliosis

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

Group 1 :

* AIS : spine deformity with angle above 10°,without detected cause
* Informed consent obtained

Group 2 :

* Secondary scoliosis due to chronic illness, neurologic or syndromic, eligible for spine surgery
* Spine surgery for reason other than scoliosis
* Informed consent obtained

Exclusion Criteria

* Not primary scoliosis
* No consent
* Legal obstacle
Minimum Eligible Age

12 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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SALLES Jean-Pierre, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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University Hospital of Toulouse

Toulouse, , France

Site Status

Countries

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France

References

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Sales de Gauzy J, Gennero I, Delrous O, Salles JP, Lepage B, Accadbled F. Fasting total ghrelin levels are increased in patients with adolescent idiopathic scoliosis. Scoliosis. 2015 Nov 30;10:33. doi: 10.1186/s13013-015-0054-7. eCollection 2015.

Reference Type RESULT
PMID: 26628906 (View on PubMed)

Other Identifiers

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Local Grant 2009

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

09 160 02

Identifier Type: -

Identifier Source: org_study_id

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