Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-03-01 @ 4:13 PM
Study NCT ID:
NCT02868905
Status:
UNKNOWN
Last Update Posted:
2016-08-16
First Post:
2016-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of Epigenetic Markers Common to Obesity and Alzheimer's Disease in Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'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'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-11', 'studyFirstSubmitDate': '2016-08-11', 'studyFirstSubmitQcDate': '2016-08-11', 'lastUpdatePostDateStruct': {'date': '2016-08-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Methylation of CpG islands in genomic DNA and in 4 target genes involved in AD (APP, SorLA/LR11, BACE1, LRP) in obese and AD subjects', 'timeFrame': 'day 0'}], 'secondaryOutcomes': [{'measure': 'body mass index', 'timeFrame': 'day 0'}, {'measure': 'visceral fat mass level', 'timeFrame': 'day 0'}, {'measure': 'leptinemia by ELISA', 'timeFrame': 'day 0'}, {'measure': 'insulinemia by ELISA', 'timeFrame': 'day 0'}, {'measure': 'glycemia', 'timeFrame': 'day 0'}, {'measure': 'triglyceridemia', 'timeFrame': 'day 0'}, {'measure': 'HDL cholesterol level in blood', 'timeFrame': 'day 0'}, {'measure': 'Reactive C protein level in blood', 'timeFrame': 'day 0'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity', "Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to compare average methylation of epigenetic markers on genomic DNA and some genes (APP, BACE, LRP, SorL1) involved in cerebral amyloid homeostasis:\n\n* Of obese young adults and healthy young adults\n* Of obese young adults and individuals affected by Alzheimer's disease (AD) having been obese at young adult age (\\<50 years old) or individuals affected by Alzheimer's disease (AD) having never been obese.\n\nThe secondary purpose is to determine if there is an association between the frequency of these epigenetic markers and elements associated to the metabolic syndrome (lipidic and glycemic analysis, leptinemia, inflammation markers) and clinical ones (visceral fat mass, body mass index) in young adults."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nGroup 1:\n\n* 18-50 year old women, age- (10 years) and sociocultural-matched with group 2\n* Non obese and never been obese\n* 18.5 \\< BMI \\< 25\n* Folstein MMS \\> 27\n* Informed consent\n* Affiliation to social security plan\n\nGroup 2:\n\n* 18-50 year old women, age- (10 years) and sociocultural-matched with group 1\n* Waist size \\> 88cm\n* 30 \\< BMI \\< 45\n* Insulin-resistant patients (Insulin resistance index, HOMA-IR \\> 3.8)\n* Obesity onset during childhood (pre-puberty period)\n* Folstein MMS \\> 27\n* Informed consent\n* Affiliation to social security plan\n\nGroup 3:\n\n* \\>60 year old women, age- (10 years) matched with group 4\n* No obesity history (18.5 ≤ BMI \\< 25 at adult age)\n* Sporadic forms of mild to moderate AD with demonstration of AD physiopathologic process according to new recommendations of 2011 of National Institute on Aging and Alzheimer's Association on diagnostic guidelines for Alzheimer's disease\n* 15\\< Folstein MMS ≤ 26\n* Informed consent\n* Affiliation to social security plan\n\nGroup 4:\n\n* \\>60 year old women, age- (10 years) matched with group 3\n* Obesity history (BMI \\> 30 at least one time at adult age)\n* Sporadic forms of mild to moderate AD with demonstration of AD physiopathologic process according to new recommendations of 2011 of National Institute on Aging and Alzheimer's Association on diagnostic guidelines for Alzheimer's disease\n* 15 \\< Folstein MMS ≤ 26\n* Informed consent\n* Affiliation to social security plan\n\nExclusion Criteria:\n\nGroup 1:\n\n* \\<18\n* Patient under guardianship, curatorship or judicial protection\n* Folate supplementation\n* Diabetic or glucose intolerant subjects\n* Present participation to another study with neuropsychological evaluation and/or drug administration\n* Pregnant women\n\nGroups 2,3 and 4:\n\n* \\<18\n* Patient under guardianship, curatorship or judicial protection\n* Folate supplementation\n* Present participation to another study with neuropsychological evaluation and/or drug administration\n\nGroup 2:\n\n\\- Pregnant women\n\nGroup 4:\n\n\\- Obese or overweight patients (BMI\\>25)"}, 'identificationModule': {'nctId': 'NCT02868905', 'acronym': 'Oba', 'briefTitle': "Identification of Epigenetic Markers Common to Obesity and Alzheimer's Disease in Women", 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': "Identification of Epigenetic Markers Common to Obesity and Alzheimer's Disease in Women - Pilot Study", 'orgStudyIdInfo': {'id': '2015-A01686-43'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control group', 'description': 'Control group', 'interventionNames': ['Procedure: Blood sample']}, {'type': 'OTHER', 'label': 'Obese group', 'description': 'Obese group', 'interventionNames': ['Procedure: Blood sample']}, {'type': 'OTHER', 'label': 'Non-obese AD group', 'description': 'Non-obese AD groups', 'interventionNames': ['Procedure: Blood sample']}, {'type': 'OTHER', 'label': 'Obese AD group', 'description': 'Obese AD group', 'interventionNames': ['Procedure: Blood sample']}], 'interventions': [{'name': 'Blood sample', 'type': 'PROCEDURE', 'armGroupLabels': ['Control group', 'Non-obese AD group', 'Obese AD group', 'Obese group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nancy', 'country': 'France', 'facility': 'CHRU de Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'centralContacts': [{'name': 'Thérèse RIVASSEAU-JONVEAUX, Dr', 'role': 'CONTACT', 'email': 't.jonveaux@chru-nancy.fr'}], 'overallOfficials': [{'name': 'Thérèse RIVASSEAU-JONVEAUX', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de Gériatrie, Hôpitaux de Brabois, 3 rue du Morvan, 54 511 Vandoeuvre-lès-Nancy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}