Ghrelin Resistance in Adolescents With Idiopathic Scoliosis

Not Applicable

Completed

• Conditions: Scoliosis
• Interventions: Biological: Osteoblast sample

• Registration Number: NCT02829476
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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

Not available

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Study First Submitted: 2016-07-04
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-10
• Last Update Posted: 2017-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control patients	Osteoblast sample	-
patients with AIS	Osteoblast sample	Patients will have 'Osteoblast sample'

Primary Outcome Measures

Name	Time	Method
Testing ghrelin cellular resistance by intracellular cAMP dosage	baseline	Testing ghrelin cellular resistance in AIS by measuring the variation of the intracellular cAMP level in response to ghrelin in osteoblast cells in vitro of AIS patients versus controls

Secondary Outcome Measures

Name	Time	Method
ghrelin levels in cellular supernatants	baseline	Measure the ghrelin levels in cellular supernatants of osteoblasts from AIS and controls patients in order to evaluate the ghrelin production of the cells.
ghrelin level in serum	baseline	Measure the ghrelin level in the serum of AIS patients versus controls

Trial Locations

Locations (1)

University Hospital of Toulouse; 🇫🇷 Toulouse, France