Ghrelin Resistance in Adolescents With Idiopathic Scoliosis

Scoliosis Clinical Trial

Official title:

Ghrelin Cellular Resistance Study in Adolescents With Idiopathic Scoliosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02829476
• Other study ID #: 09 160 02
• Secondary ID: Local Grant 2009
• Status: Completed
• Phase: N/A
• First received: July 4, 2016
• Last updated: May 10, 2017
• Start date: March 2010
• Est. completion date: July 2012

Study information

• Verified date: May 2017
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Scoliosis

Intervention

Biological:
• Osteoblast sample
culture osteoblasts obtained from vertebrae fragments from 30 patients with AIS and from 10 control patients with secondary scoliosis

Locations

Country	Name	City	State
France	University Hospital of Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Testing ghrelin cellular resistance by intracellular cAMP dosage	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	baseline
Secondary	ghrelin level in serum	Measure the ghrelin level in the serum of AIS patients versus controls	baseline
Secondary	ghrelin levels in cellular supernatants	Measure the ghrelin levels in cellular supernatants of osteoblasts from AIS and controls patients in order to evaluate the ghrelin production of the cells.	baseline