ScoliosisNCT02829476
Ghrelin Resistance in Adolescents With Idiopathic Scoliosis
A study testing Osteoblast sample in people with Scoliosis, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 12 to 15 years
- Conditions the study is for
- Scoliosis
- What is being tested?
- Osteoblast sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2010to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Not primary scoliosis
- No consent
- Legal obstacle
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Scoliosis
- Being tested
- Osteoblast sample
- Keywords
- Adolescent idiopathic Scoliosis, Ghrelin
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteoblast sampleBiological
culture osteoblasts obtained from vertebrae fragments from 30 patients with AIS and from 10 control patients with secondary scoliosis
| Study group | Role | What they receive |
|---|---|---|
| patients with AIS | Experimental | Patients will have 'Osteoblast sample' Receives: Biological: Osteoblast sample |
| control patients | Experimental | Not described Receives: Biological: Osteoblast sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Secondary outcomes (2)
ghrelin level in serum
Measure the ghrelin level in the serum of AIS patients versus controls
Measured: baseline
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startMar 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SALLES Jean-Pierre, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829476
- Sponsor's protocol ID
- 09 160 02
- Other IDs
- Local Grant 2009
- Status last verified
- May 2017
- First submitted
- 4 Jul 2016
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26628906
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ghrelin Cellular Resistance Study in Adolescents With Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT02829476
- Acronym / sponsor ID
- 09 160 02
- Conditions
- Scoliosis
- Keywords
- Adolescent idiopathic Scoliosis, Ghrelin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with AIS | Experimental | Biological: Osteoblast samplePatients will have 'Osteoblast sample' |
| control patients | Experimental | Biological: Osteoblast sample |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- AIS : spine deformity with angle above 10°,without detected cause
- Informed consent obtained
- Secondary scoliosis due to chronic illness, neurologic or syndromic, eligible for spine surgery
- Spine surgery for reason other than scoliosis
- Informed consent obtained
Key exclusion criteria (3 listed)
- Not primary scoliosis
- No consent
- Legal obstacle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteoblast sampleculture osteoblasts obtained from vertebrae fragments from 30 patients with AIS and from 10 control patients with secondary scoliosis | Biological | control patients, patients with AIS |
Primary outcome
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
2 secondary outcomes
ghrelin level in serum
Time frame: baseline
ghrelin levels in cellular supernatants
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Results publication: PubMed 26628906Sales 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.
- Individual participant dataSharing planned: No
Related trials for Scoliosis
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Recruiting
Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
Scoliosis Idiopathic, Scoliosis; Adolescence
RecruitingObservational study
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SALLES Jean-Pierre, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteoblast sample in people with Scoliosis, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testing ghrelin cellular resistance by intracellular cAMP dosage (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02829476, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2017.