Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2026-01-02 @ 5:56 AM
Study NCT ID:
NCT05503303
Status:
COMPLETED
Last Update Posted:
2022-08-19
First Post:
2022-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
T1D, Metabolic Syndrome and Insulin Resistance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-16', 'studyFirstSubmitDate': '2022-08-13', 'studyFirstSubmitQcDate': '2022-08-13', 'lastUpdatePostDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycated hemoglobin', 'timeFrame': 'March 2022', 'description': 'Concentrations by an enzymatic immunoassay method'}, {'measure': 'Total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols', 'timeFrame': 'March 2022', 'description': 'Determined in blood serum using a Clinical Chemistry System from Random Access Diagnostics'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes', 'Metabolic Syndrome', 'Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'Patients with type 1 diabetes (T1D) and metabolic syndrome (MS) require high doses of insulin to achieve a glycemic control, due to insulin resistance (IR). The investigators identified the presence of metabolic syndrome and insulin resistance in patients with T1D in a population of southeast Mexico.\n\nThe sampled population was recruited from the Diabetes Clinic of the Regional Hospital of High Specialty "Dr. Gustavo A. Rovirosa Pérez"; from August 2021 to February 2022, graduated physicians interviewed patients previously diagnosed with T1D. This study included patients older than 18 years and at least six months after being diagnosed with T1D. The interviewers excluded patients who did not attend regular consultations and those who did not agree to participate or to give a blood sample. A diabetologist evaluated and diagnosed all patients based on the World Health Organization (WHO) criteria.\n\nFasting glucose, total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols were determined in blood serum using a Clinical Chemistry System from Random Access Diagnostics. The reasearch team determined glycated hemoglobin concentrations by an enzymatic immunoassay method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who attend Diabetes Clinic of the Regional Hospital of High Specialty "Dr. Gustavo A. Rovirosa Pérez", previously diagnosed with type 1 diabetes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least six months after being diagnosed with T1D\n\nExclusion Criteria:\n\n* Did not attend regular consultations\n* Did not agree to participate or to give a blood sample'}, 'identificationModule': {'nctId': 'NCT05503303', 'briefTitle': 'T1D, Metabolic Syndrome and Insulin Resistance', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Juárez Autónoma de Tabasco'}, 'officialTitle': 'Clinical Characteristics in Adults With Type 1 Diabetes, Metabolic Syndrome and Insulin Resistance', 'orgStudyIdInfo': {'id': 'T1D-DACS2022'}}, 'contactsLocationsModule': {'locations': [{'zip': '86090', 'city': 'Villahermosa', 'state': 'Tabasco', 'country': 'Mexico', 'facility': 'Isela Esther Juarez Rojop', 'geoPoint': {'lat': 17.98625, 'lon': -92.93928}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Juárez Autónoma de Tabasco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full-Time Investigator Professor', 'investigatorFullName': 'ISELA ESTHER JUAREZ-ROJOP Ph.D.', 'investigatorAffiliation': 'Universidad Juárez Autónoma de Tabasco'}}}}