Ghrelin Resistance in Adolescents With Idiopathic Scoliosis

May 10, 2017 updated by: University Hospital, Toulouse

Ghrelin Cellular Resistance Study in Adolescents With Idiopathic Scoliosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31000
        • University Hospital of Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 15 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: patients with AIS
Patients will have 'Osteoblast sample'
Biological: Osteoblast sample
culture osteoblasts obtained from vertebrae fragments from 30 patients with AIS and from 10 control patients with secondary scoliosis
EXPERIMENTAL: control patients
Biological: Osteoblast sample
culture osteoblasts obtained from vertebrae fragments from 30 patients with AIS and from 10 control patients with secondary scoliosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Testing ghrelin cellular resistance by intracellular cAMP dosage
Time Frame: 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
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ghrelin level in serum
Time Frame: baseline
Measure the ghrelin level in the serum of AIS patients versus controls
baseline
ghrelin levels in cellular supernatants
Time Frame: 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.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: SALLES Jean-Pierre, MD, University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

July 4, 2016

First Submitted That Met QC Criteria

July 11, 2016

First Posted (ESTIMATE)

July 12, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 12, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09 160 02
  • Local Grant 2009 (Other Grant/Funding Number: 0916302)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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