Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2026-04-18 @ 1:57 PM
Study NCT ID:
NCT02975427
Status:
COMPLETED
Last Update Posted:
2016-11-29
First Post:
2016-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioimpedance Analysis for Follow-up of Dieters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-28', 'studyFirstSubmitDate': '2016-10-27', 'studyFirstSubmitQcDate': '2016-11-28', 'lastUpdatePostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Value of abdominal BIA for the follow up of dieting individual', 'timeFrame': '3 months (plus or minus 1 month)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diet', 'Abdominal bioelectrical impedance analysis', 'Anthropometry', 'Insulin resistance'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'Prospective, single arm, dietary intervention study.', 'detailedDescription': 'This prospective study was conducted during the period from December 2011 through June 2013 in the Department of Endocrinology and Metabolism of Başkent University.\n\nWe enrolled 185 participants who were admitted to hospital for weight loss therapy. After initial evaluation, all participants were prescribed an appropriate diet with caloric restriction and an exercise program and underwent a follow-up examination 3±1 months later. At the end of the follow up, 103 participants attended to the research. Anthropometric, bioimpedance and laboratory measurements performed at baseline and second visit. We calculated the difference in anthropometric, bioimpedance and laboratory measurements between the first and second evaluations. Correlation analysis, multivariate linear regression analysis and receiver operating characteristic analysis performed to assess associations of laboratory metabolic variables with a decrease in anthropometric and bioimpedance analysis (BIA) measures, after diet and/or exercise therapy. The secondary aim was to determine whether abdominal BIA was better than simple anthropometric measurements and conventional BIA for assessing changes in metabolic variables.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'One hundred and eighty five participants who were admitted to hospital for weight loss therapy enrolled to the study. After initial evaluation, all participants were prescribed an appropriate diet with caloric restriction and an exercise program and underwent a follow-up examination 3±1 months later. A total of 134 participants reported for the second visit; 51 did not. Thirty one participants who, at the second visit, reported that they failed to adhere to the diet were excluded from the analysis . Ultimately, data from 103 participants who reported that they adhered to the diet were included in the analysis.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants aged 18 to 70 years without chronic disease, cancer, a pacemaker, cardiac valve replacement, malabsorption syndrome, previous history of gastrointestinal surgery, thyroid disease, pregnancy, or a history of surgery during the previous 3 months.\n\nExclusion Criteria:\n\n* Participants receiving oral antidiabetic drugs, insulin, any treatment for obesity, steroids or hormonal drugs, over-the-counter drugs for weight loss, any kind of phytodrug, or any drug that could affect glucose metabolism. We also excluded patients who used any of these drugs after the initial evaluation.\n* Participants who, at the second visit, reported that they failed to adhere to the diet.'}, 'identificationModule': {'nctId': 'NCT02975427', 'acronym': 'BIA', 'briefTitle': 'Bioimpedance Analysis for Follow-up of Dieters', 'organization': {'class': 'OTHER', 'fullName': 'Baskent University Ankara Hospital'}, 'officialTitle': 'Abdominal Bioelectric Impedance for Follow-up of Dieters: A Prospective Study', 'orgStudyIdInfo': {'id': 'KA12/192'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diet group', 'description': 'All participants were prescribed an appropriate diet with caloric restriction and an exercise program and underwent a follow-up examination 3±1 months later.', 'interventionNames': ['Other: Diet group']}], 'interventions': [{'name': 'Diet group', 'type': 'OTHER', 'description': 'All participants were prescribed an appropriate diet with caloric restriction and an exercise program and underwent a follow-up examination 3±1 months later.', 'armGroupLabels': ['Diet group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Yusuf Bozkuş, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baskent University Ankara Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baskent University Ankara Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Yusuf Bozkuş', 'investigatorAffiliation': 'Baskent University Ankara Hospital'}}}}