Nctid:
NCT06229899
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M12701", "name"=>"Obesity", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"bioSpec"=>{"retention"=>"SAMPLES_WITHOUT_DNA", "description"=>"blood samples for follistatin"}, "studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"CROSS_SECTIONAL", "observationalModel"=>"CASE_CONTROL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>62}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2022-01-15", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2023-01-15", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-27", "studyFirstSubmitDate"=>"2024-01-15", "studyFirstSubmitQcDate"=>"2024-01-26", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-01-15", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"relation between follistatin and metabolically healthy and unhealthy obesity", "timeFrame"=>"baseline", "description"=>"This study aims to examine the correlation between follistatin levels and both metabolically healthy and unhealthy individuals with obesity"}, {"measure"=>"threshold for follistatin in metabolic evaluation of obesity", "timeFrame"=>"baseline", "description"=>"The establishment of a threshold value for follistatin levels in assessing metabolic health in obese individuals."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Obesity"]}, "descriptionModule"=>{"briefSummary"=>"There is no clear boundary on which obese individuals should be considered metabolically healthy and which should be considered metabolically unhealthy. It is also not very clear whether the individuals who are considered metabolically healthy will remain healthy in the future. The objective of this study was to assess potential disparities in serum follistatin levels between these two distinct groups. Furthermore, the study sought to investigate whether this disparity could serve as a reliable indicator for distinguishing between metabolically healthy and unhealthy obese individuals.", "detailedDescription"=>"Individuals with similar body mass indexes may have different metabolic health and cardiovascular risks. Research shows that some individuals with comparable body mass index (BMI) are metabolically healthy and have a lower risk of cardiovascular issues, while others are metabolically unhealthy and have a higher risk. Studies indicate that the lifestyles of metabolically healthy and unhealthy obese individuals, such as diet, physical activity, and sleep patterns, do not differ significantly, even though the individuals have similar levels of total or subcutaneous adiposity. However, it has been shown that metabolically healthy obese individuals tend to have lower levels of visceral adiposity compared to unhealthy ones.\n\nPatients with BMI≥30, who applied to the internal medicine clinic, were included in the study. Among these patients, those without criteria of metabolic syndrome other than an increase in waist circumference (blood pressure ≥130/85 mmHg, fasting blood sugar ≥100 mg/dl, triglycerides ≥150 mg/dl, HDL-cholesterol \\<40 mg/dl in men and \\<50 mg/dl in women) and without prediabetes were defined as metabolically healthy obese individuals. Those with at least 1 metabolic syndrome criterion other than an increase in waist circumference were classified as metabolically unhealthy obese individuals. The participants' fasting blood sugar levels, HbA1c levels, insulin levels, lipid panel results, liver enzymes levels,urea levels, creatinine levels, whole blood count, and thyroid hormones were examined. Anthropometric measurements including height,weight and waist circumference were also taken for each individual.\n\nParticipants were then invited back to repeat follistatin levels."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"60 years", "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Individuals between 18-60 years old, with a BMI of ≥ 30, who are not using any medication or have any disease that may effect their glycemia, lipid profiles or blood pressure.", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Having given consent to the study\n* Being over 18 years of age\n* Being under 60 years of age\n* Body mass index \\>=30 kg/m2\n\nExclusion Criteria:\n\n* Antidiabetic medication usage\n* obesity surgery\n* Antihypertensive medication usage\n* Those receiving lipid-lowering therapy\n* Pregnant women\n* Those with hypo/hyperthyroidism\n* Steroid use\n* Benign/malignant tumors\n* Advanced liver disease\n* Secondary causes of obesity"}, "identificationModule"=>{"nctId"=>"NCT06229899", "briefTitle"=>"Follistatin Levels in Metabolically Healthy and Unhealthy Obese Individuals", "organization"=>{"class"=>"OTHER", "fullName"=>"Goztepe Prof Dr Suleyman Yalcın City Hospital"}, "officialTitle"=>"Can Follistatin Levels Help Distinguish Between Metabolically Healthy and Unhealthy Obese Individuals", "orgStudyIdInfo"=>{"id"=>"Metabolic health-Follistatin"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"metabolically healthy individuals with obesity", "description"=>"Individuals with BMI ≥30 , those without criteria of metabolic syndrome other than an increase in waist circumference (blood pressure ≥130/85 mmHg, fasting blood sugar ≥100 mg/dl, triglycerides ≥150 mg/dl, HDL-cholesterol \\<40 mg/dl in men and \\<50 mg/dl in women) and without prediabetes", "interventionNames"=>["Diagnostic Test: Serum follistatin levels"]}, {"label"=>"metabolically unhealthy individuals with obesity", "description"=>"Individuals with BMI ≥30 , and have one of the followings: blood pressure ≥130/85 mmHg, fasting blood sugar ≥100 mg/dl, triglycerides ≥150 mg/dl, HDL-cholesterol \\<40 mg/dl in men and \\<50 mg/dl in women", "interventionNames"=>["Diagnostic Test: Serum follistatin levels"]}], "interventions"=>[{"name"=>"Serum follistatin levels", "type"=>"DIAGNOSTIC_TEST", "description"=>"blood samples are taken", "armGroupLabels"=>["metabolically healthy individuals with obesity", "metabolically unhealthy individuals with obesity"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Istanbul", "country"=>"Turkey", "facility"=>"Istanbul Medeniyet University Goztepe Research and TRaining Hospital", "geoPoint"=>{"lat"=>41.01384, "lon"=>28.94966}}], "overallOfficials"=>[{"name"=>"Ayşe N Erbakan, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Istanbul Medeniyet University Goztepe Research and TRaining Hospital"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Goztepe Prof Dr Suleyman Yalcın City Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal investigator", "investigatorFullName"=>"Ayse N Erbakan", "investigatorAffiliation"=>"Goztepe Prof Dr Suleyman Yalcın City Hospital"}}}}
