Microarray Analysis in Syndromic Obesity (REMOB)
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ClinicalTrials.gov Identifier: NCT01043198 |
Recruitment Status :
Completed
First Posted : January 6, 2010
Last Update Posted : June 14, 2012
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Condition or disease | Intervention/treatment | Phase |
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Mental Retardation Syndromic Obesity | Genetic: Clinical examination and blood sampling for biological and genetic analysis | Not Applicable |
With the introduction of array comparative genomic hybridization (CGH), genome-wide high resolution analysis for DNA copy number alterations became feasible. This technology has been principally used in patients with mental retardation. Depending on the eligibility criteria and resolution of the array, around 10 % of patients with mental retardation are found with cryptic chromosomal imbalance. This figure arises 20 % for patients with mental retardation and multiple congenital anomalies. Alteration of the lipid metabolism and/or regulation of satiety, obesity (except in presence of other "exogen" factors) can be considered as a developmental disorder. Also, different syndromes with obesity have been associated with chromosomal abnormalities, such as 1p36 deletion syndrome, 2q37 deletion syndrome, chromosome 14 maternal disomy … So we can expect that syndromic obesity is similarly associated with sub cryptic chromosomal abnormalities. Some "isolated" patients with obesity have been described with cryptic chromosomal imbalance found by array CGH, but no study has been realized in cohorts of patients selected for syndromic obesity.
Characterization of cryptic chromosomal anomaly(ies) in a patient will also be useful to precise the management and follow-up of the patient and to give the family an adapted genetic counselling.
We will define a cohort of patients with syndromic obesity and propose them to realize a first screening looking for the "common" aetiologies of syndromic obesity. If this screening is normal, array CGH will be realized. This analysis implies a blood sampling of 5 ml in patient and his parents.
Genes present at the deleted or duplicated loci characterized in the patients will be study to determine if some could be specifically implicated in the development of obesity. These same genes could be implicated in isolated obesity. Our study will be also useful to precise the aetiological screening of syndromic obesity, and determine the place of array-CGH.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 90 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Phenotypic Characterization and Array CGH Analysis in Patients With Syndromic Obesity of Unknown Etiology |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | January 2011 |
Actual Study Completion Date : | January 2011 |

- Genetic: Clinical examination and blood sampling for biological and genetic analysis
Clinical examination and precise description of the phenotype (questionnaire)
- Standardized screening with :
- radiological (hands, feet, spine ; and renal ultrasonography)
- biological (hormonal, metabolic, and "basic" genetic investigations (karyotype, FISH 22q11.2, Fragile X, and other depending on the clinical data))
- Evaluation of the prevalence of cryptic chromosomal imbalance in patients with syndromic obesity of unknown etiology. [ Time Frame: 3 - 6 months ]
- prevalence of the main genetic aetiologies of syndromic obesity [ Time Frame: 3 - 6 months ]
- Characterization of the main features evocative of subcryptic chromosomal anomalies in this population [ Time Frame: 3 - 6 months ]
- Phenotypic description of some "new" syndromes with obesity [ Time Frame: 3 - 6 months ]
- candidate genes implicated in the development of obesity. [ Time Frame: 3 - 6 months ]
- Delineation of an aetiological screening protocol in patients with syndromic obesity [ Time Frame: 3 - 6 months ]

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Ages Eligible for Study: | up to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- children (under 18 year-old)
- obesity (following IOTF definition)
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at least one criteria among :
- mental retardation
- facial dysmorphism
- at least one major malformation (uro-genital, cardiac, skeletal, cerebral, ophthalmologic…)
Exclusion Criteria:
- common obesity
- obesity with an identified aetiology

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01043198
France | |
Service de Génétique de médicale - Hopital des enfants - Pellegrin | |
Bordeaux, France, 33076 | |
Centre de Génétique Hôpital d'Enfants CHU de Dijon | |
Dijon, France, 21079 | |
Génétique Médicale HOPITAL DEBROUSSE HCL | |
Lyon, France, 69005 | |
Département de Génétique Médicale Centre de référence anomalies du développement Centre de compétence maladies osseuses constitutionnelles Hôpital Arnaud de Villeneuve CHRU Montpellier | |
Montpellier, France, 34295 | |
Département de Génétique Hôpital Robert DEBRE Centre de Référence Maladies Rares "Anomalies du Développement & Syndromes Malformatifs" | |
Paris, France, 75019 | |
Hopital des Enfants, CHU de Toulouse | |
Toulouse, France, 31059 |
Principal Investigator: | Marie-Ange DELRUE, MD | University Hospital Bordeaux, France |
Responsible Party: | University Hospital, Bordeaux |
ClinicalTrials.gov Identifier: | NCT01043198 |
Other Study ID Numbers: |
CHUBX 2009/26 |
First Posted: | January 6, 2010 Key Record Dates |
Last Update Posted: | June 14, 2012 |
Last Verified: | June 2012 |
CGH array technology mental retardation chromosomal abnormalities syndromic obesity obesity |
Intellectual Disability Obesity Overnutrition Nutrition Disorders Overweight Body Weight |
Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Neurodevelopmental Disorders Mental Disorders |