Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-30 @ 9:44 PM
Study NCT ID:
NCT04329260
Status:
UNKNOWN
Last Update Posted:
2021-01-27
First Post:
2020-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mutation of the LEPR Gene at Reunion Island: Involvement in Pediatric Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'saliva sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2020-03-30', 'studyFirstSubmitQcDate': '2020-03-30', 'lastUpdatePostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of the Δ6-8 deletion of the LEPR gene in paediatric population', 'timeFrame': 'at inclusion', 'description': 'Presence of the deletion of the LEPR gene'}], 'secondaryOutcomes': [{'measure': 'Proportion of the Δ6-8 deletion of the LEPR gene in adult family members', 'timeFrame': '6 months after inclusion of the paediatric population', 'description': 'Presence of the deletion of the LEPR gene'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity, Childhood']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to estimate the proportion of the recurrent deletion Δ6-8 of the LEPR gene in the homozygous and heterozygous state in pediatric cases with severe and early ( before the age of 6) obesity (BMI ≥ IOTF-30) on Reunion Island.', 'detailedDescription': 'The study of the deletion Δ6-8 of the LEPR gene starts with a saliva sample using a swab in children aged between 3 to 18 years old.\n\nThe DNA from this sample will then be analyzed by the PCR technique. If the deletion of the LEPR gene is confirmed in the patient, his adult family members will also be screened using the same procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children between 3 to 18 years old with severe obesity (BMI\\>30) and adult family members.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient with early severe and non syndromic obesity (BMI\\> IOTC-30) (before 6 years old)\n* adult family members with deletion of LEPR gene\n* informed consent form signed by participants or parents\n* affiliation to social security scheme\n\nExclusion Criteria:\n\n* patient with syndromic obesity\n* patient Under guardianship or Under judicial protection'}, 'identificationModule': {'nctId': 'NCT04329260', 'acronym': 'GREOL', 'briefTitle': 'Mutation of the LEPR Gene at Reunion Island: Involvement in Pediatric Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de la Réunion'}, 'officialTitle': 'Mutation of the LEPR Gene at Reunion Island: Involvement in Pediatric Obesity GRÉOL (Génétique Réunion Obésité LEPR)', 'orgStudyIdInfo': {'id': '2019/CHU/04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatric population', 'description': 'Children between 3 to 18 years old with severe (BMI\\> IOTF-30) and early (before the age of 6) obesity.\n\nA Saliva sample for screening of the deletion Δ6-8 of LEPR gene will be performed for each child.'}, {'label': 'Adult member family', 'description': 'The screening of the same deletion according the same procedure will be proposed to the adult family member if the child presents the deletion Δ6-8 of LEPR gene.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Emilie TECHER', 'role': 'CONTACT', 'email': 'emilie.techer@chu-reunion.fr', 'phone': '+262 262 90 62 89'}], 'overallOfficials': [{'name': 'Paul GUEGUEN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de La Réunion'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de la Réunion', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}