Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-02-28 @ 2:28 PM
Study NCT ID:
NCT03363594
Status:
COMPLETED
Last Update Posted:
2020-06-16
First Post:
2017-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Indian Phenotype Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-12', 'studyFirstSubmitDate': '2017-11-20', 'studyFirstSubmitQcDate': '2017-11-30', 'lastUpdatePostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate total body fat content across various BMI categories in the study population', 'timeFrame': '1 day', 'description': 'Bioelectrical impedance will be used to estimate how much % body fat in terms of weight compared to total body weight.\n\nSince it is a ratio (weight of fat/total body weight) so no unit is required. The ratio will be multiplied by 100 to get Fat percentage.'}], 'secondaryOutcomes': [{'measure': 'To analyse different characteristics of Diabetes Mellitus patient in study population', 'timeFrame': '1 day', 'description': 'patient characteristics like age, gender'}, {'measure': 'To correlate HbA1C level with various BMI categories', 'timeFrame': '1 day', 'description': 'Weight in kilogram, height in meter will be combined to report BMI in kg/m2. then HbA1c in percentage and BMI in kg/m2 will be aggregated to get correlation'}]}, 'conditionsModule': {'keywords': ['Diabetes, T2D'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D1843R00282&attachmentIdentifier=f06144e6-5b1b-4200-bd96-e4315aaf6d57&fileName=D1843R00282_CSR_synopsis_redacted.pdf&versionIdentifier=', 'label': 'redacted CSR synopsis'}]}, 'descriptionModule': {'briefSummary': "This study is a non-interventional, multicentre observational study to be conducted at 1000 sites in India. The study targets to enrol approx. 50000 patients with approx. 50 patients per site. The study would enrol Diabetes Mellitus patients who provides written informed consent. No study medication will be prescribed or administered as a part of study procedure. Patients, who have been treated as per Investigators' routine clinical practice will be screened for enrolment in study. The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB).", 'detailedDescription': "This study is a non-interventional, multicentre observational study to be conducted at 1000 sites in India. The study targets to enrol approx. 50000 patients with approx. 50 patients per site. The study would enrol Diabetes Mellitus patients who provides written informed consent. No study medication will be prescribed or administered as a part of study procedure. Patients, who have been treated as per Investigators' routine clinical practice will be screened for enrolment in study. The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB).\n\nThis is a single visit cross sectional study however during site feasibility visit, probability of follow-up of these patients will be evaluated. If feasible protocol will be amended to continue data collection prospectively for appropriate duration"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Diabetes Mellitus patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Male or female patients with 18 years and above.\n2. Patients who provide written informed consent.\n3. Patients with previously diagnosed with Diabetes Mellitus\n4. HbA1C report available within past 3 months\n\nExclusion Criteria- None'}, 'identificationModule': {'nctId': 'NCT03363594', 'acronym': 'IP Registry', 'briefTitle': 'Indian Phenotype Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Non-interventional Nationwide Registry to Identify Indian Phenotype Characteristics in Diabetes Mellitus Patients in India.', 'orgStudyIdInfo': {'id': 'D1843R00282'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Diabetes Mellitus'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D1843R00282', 'city': 'Guntur', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 16.29974, 'lon': 80.45729}}, {'zip': 'D1843R00282', 'city': 'Kākināda', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 16.96036, 'lon': 82.23809}}, {'zip': 'D1843R00282', 'city': 'Madanapalle', 'state': 'Andhra Pradesh', 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