Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-26 @ 1:48 AM
Study NCT ID:
NCT04218305
Status:
COMPLETED
Last Update Posted:
2020-01-06
First Post:
2020-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fetuin-A as a Marker in Obesity and Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2016-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-02', 'studyFirstSubmitDate': '2020-01-02', 'studyFirstSubmitQcDate': '2020-01-02', 'lastUpdatePostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1- Study of human serum fetuin-A and whether it is involved in insulin resistance', 'timeFrame': 'Baesline', 'description': '2- To assess the significance of serum fetuin-A as a marker in obesity and type 2 diabetes mellitus'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabete Type 2']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the significance of serum fetuin-A as a marker of obesity and type 2 diabetes mellitus. We used multiple statistical approaches to determine that the fetuin-A level is correlated to body mass index (BMI) as well as random blood sugar in type 2 diabetic patients. Also, we found that there is a Positive correlation between the serum fetuin-A levels and the level of glycosylated hemoglobin (HbA1c) in diabetic patients.', 'detailedDescription': 'The study was a case-control study. We started the study to be performed on eighty subjects divided into four groups:\n\nThe first group: include twenty subjects with type 2 diabetes mellitus The second group: include twenty obese subjects whose body mass index is 30 or over The third group: include twenty obese subjects with type 2 diabetes mellitus The fourth group includes twenty apparently healthy subjects as control.\n\nIn this study, we concluded that:\n\n1. Serum fetuin-A can be used as a biomarker and independent risk factor and marker for diagnosis of DM and DM has a detrimental effect on serum fetuin-A fetuin-A could be of relevance for the development of insulin resistance\n2. Higher fetuin-A concentrations were associated with type 2 diabetes and insulin resistance\n3. Increased serum fetuin-A levels constitute an independent marker of lipid profile.\n4. fetuin-A may play a role in the pathogenesis of T2DM.\n5. The inhibition of insulin receptor by fetuin-A may lead to increased lipolysis and efflux of free fatty acids from adipose tissue. This could explain associated dyslipidemia observed in type 2 diabetic patients in the present study.\n\nFinally, our finding that high plasma fetuin-A levels predict the incidence of type 2 diabetes independently of other established risk factors supports the hypothesis that fetuin-A may play a role in the development of type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'obese and type 2 diabetic patients aged 45-60 years old. and control healthy adult persons', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • The study included obese and type 2 diabetic patients aged 45-60 years old. and control healthy adult persons\n\nExclusion Criteria:\n\n* • Cardiac disease and Hypertensive disease\n\n * Respiratory disease\n * Renal disease\n * GIT and Liver disease\n * Rheumatologic disease\n * Blood disease\n * Endocrine disease except for type 2 diabetes mellitus\n * All with a specific therapeutic drug history.'}, 'identificationModule': {'nctId': 'NCT04218305', 'briefTitle': 'Fetuin-A as a Marker in Obesity and Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Study of Using Serum Fetuin-A as a Marker in Obesity and Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'fetuin-A as a marker'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'The first group', 'description': 'Include One hundred patients with type 2 diabetes mellitus with average body mass index.', 'interventionNames': ['Diagnostic Test: Serum Level Of Fetuin A']}, {'label': 'The second group', 'description': 'Include One hundred patients whose body mass index is 30 or over without diabetes.', 'interventionNames': ['Diagnostic Test: Serum Level Of Fetuin A']}, {'label': 'The third group', 'description': 'Include One hundred type 2 diabetic obese patients whose body mass index is 30 or over.', 'interventionNames': ['Diagnostic Test: Serum Level Of Fetuin A']}, {'label': 'The fourth group', 'description': 'Include One hundred apparently healthy adult person as a control.', 'interventionNames': ['Diagnostic Test: Serum Level Of Fetuin A']}], 'interventions': [{'name': 'Serum Level Of Fetuin A', 'type': 'DIAGNOSTIC_TEST', 'armGroupLabels': ['The first group', 'The fourth group', 'The second group', 'The third group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Hosam Mohammad Ahmad', 'investigatorAffiliation': 'Minia University'}}}}