Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT04205318
Status:
COMPLETED
Last Update Posted:
2019-12-19
First Post:
2019-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FTO Gene Variants and Diet in Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D020022', 'term': 'Genetic Predisposition to 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': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D004198', 'term': 'Disease Susceptibility'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-17', 'studyFirstSubmitDate': '2019-07-21', 'studyFirstSubmitQcDate': '2019-12-17', 'lastUpdatePostDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Genetic analysis of two SNPs at FTO gene', 'timeFrame': 'up to 36 weeks', 'description': 'FTO SNPs rs9939609 and rs10163409'}, {'measure': 'Anthropometric measurements', 'timeFrame': 'up to 36 weeks', 'description': 'Body mass index, waist circumference, hip circumference, body composition'}, {'measure': 'Biochemical measurements', 'timeFrame': 'up to 36 weeks', 'description': 'lipid profile, glucose, insulin, adiponectin'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity', 'gene-diet interaction', 'FTO gene variant'], 'conditions': ['Obesity', 'Diet Habit', 'Genetic Predisposition']}, 'descriptionModule': {'briefSummary': 'Studies have shown that the effect of fat mass and obesity-associated (FTO) gene on obesity is modulated by lifestyle factors. Hence, we aimed to determine whether two single nucleotide polymorphisms (SNPs) in the FTO gene are associated with obesity and to assess whether these associations were modified by lifestyle factors. The study included 200 obese and 200 non-obese individuals from Turkey. Our study suggests that the effect of the SNPs on obesity traits is likely to be influenced by lifestyle factors in this Turkish population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '24 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '400 unrelated individuals, aged 24-50 years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. attending routine outpatient visits,\n2. aged 24 to 50 years,\n3. having a BMI ≥ 18.50 kg/m2'}, 'identificationModule': {'nctId': 'NCT04205318', 'briefTitle': 'FTO Gene Variants and Diet in Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Impact of FTO Gene Variants and Lifestyle Factors on Obesity Traits in a Turkish Population', 'orgStudyIdInfo': {'id': 'GO15/612-11'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'study', 'description': 'obese (BMI ≥25.00 kg/m2, n=200)'}, {'label': 'control', 'description': 'non-obese (BMI= 18.50-24.99 kg/m2, n=200)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Zehra Buyuktuncer', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Zehra Buyuktuncer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University, Department of Nutrition and Dietetics, Ankara, TURKEY'}, {'name': 'Vimales Karani Santhanakrishnan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Food and Nutritional Sciences, University of Reading, UK'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Reading', 'class': 'OTHER'}, {'name': 'The Scientific and Technological Research Council of Turkey', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'ZEHRA BUYUKTUNCER', 'investigatorAffiliation': 'Hacettepe University'}}}}