Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-03-01 @ 10:02 AM
Study NCT ID:
NCT03673904
Status:
COMPLETED
Last Update Posted:
2018-09-17
First Post:
2018-09-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Sensitive CRP in Prediabetics and Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-14', 'studyFirstSubmitDate': '2018-09-14', 'studyFirstSubmitQcDate': '2018-09-14', 'lastUpdatePostDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'statistical significant elevation of high sensitive CRP in diabetics and prediabetes', 'timeFrame': '2 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Assess Level of High Sensitive CRP in Diabetics and Prediabetics']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to study the level of high-sensitivity CRP in sera of pre-diabetic and newly diagnosed patients with type 2 diabetes mellitus and its correlation with HOMA IR and HbA1c', 'detailedDescription': 'This study will include (180) subjects, 60 pre-diabetic patients, 60 patients with newly diagnosed type 2 diabetes ( within one month of diagnosis) and 60 normal healthy non diabetic individuals as a control group. The study individuals will be recruited from the Diabetes and Internal Medicine Clinics of Fayoum University Hospital'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study individuals were recruited from the Diabetes and Internal Medicine Clinics of Fayoum University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pre-diabetic patients:\n\n * A fasting blood glucose level (100 to 125 mg/dL). or\n * A 2-hour blood glucose level (140 to 199 mg/dL) .or\n * Hb A1C 5.7% to 6.4%.\n* Newly diagnosed type 2 diabetes: (maximum within one month from diagnosis)\n\n * A fasting blood glucose level \\>126 mg/dl\n * A 2-hour blood glucose level \\> 200 mg/dl\n * Hb A1C \\> 6.5%\n\nExclusion Criteria:\n\n* Pregnant or lactating females.\n* Patients who have recent infection.\n* Patients with acute inflammatory diseases as autoimmune diseases.\n* Patients with malignancy or on chemotherapy.\n* Patients with acute or chronic liver or renal diseases'}, 'identificationModule': {'nctId': 'NCT03673904', 'briefTitle': 'High Sensitive CRP in Prediabetics and Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Fayoum University'}, 'officialTitle': 'High Sensitive CRP Level in Prediabetics and Newly Diagnosed Type 2 Diabetic Patients', 'orgStudyIdInfo': {'id': 'D84'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prediabetics', 'description': 'Ages ranging from 18 to 60 years old,males and females were included . A fasting blood glucose level (100 to 125 mg/dL). or A 2-hour blood glucose level (140 to 199 mg/dL) .or Hb A1C 5.7% to 6.4%.'}, {'label': 'Newly diagnosed type 2 diabetes', 'description': 'Ages ranging from 18 to 60 years old,males and females were included Newly diagnosed type 2 diabetes: (maximum within one month from diagnosis) A fasting blood glucose level \\>126 mg/dl A 2-hour blood glucose level \\> 200 mg/d Hb A1C \\> 6.5%'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'still to be decided later'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fayoum University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of internal medicine', 'investigatorFullName': 'Ahmed Abdelkawi Hammad', 'investigatorAffiliation': 'Fayoum University'}}}}