Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-24 @ 5:40 PM
Study NCT ID:
NCT06724068
Status:
COMPLETED
Last Update Posted:
2024-12-12
First Post:
2024-12-03
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diabetes, Insulin Resistance and Body Composition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 515}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-07', 'studyFirstSubmitDate': '2024-12-03', 'studyFirstSubmitQcDate': '2024-12-06', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Sarcopenia in Diabetic Patients', 'timeFrame': 'Retrospective analysis of data collected between2019 and 2022', 'description': 'The proportion of diabetic patients diagnosed with sarcopenia, assessed based on measurements of muscle mass, muscle strength, and physical performance. Sarcopenia will be defined according to AWGS 2019 and EWGSOP2'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insulin Resistance, Diabetes']}, 'descriptionModule': {'briefSummary': 'The goal of this retrospective study is to learn about the correlation between diabetes, insulin resistance and body compositions.\n\nThe main question\\[s\\] it aims to answer are:\n\n* \\[The difference of body composition between the individuals of insulin resistance and diabetes\\]\n* \\[The effect of diabetes on body composition\\]'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study includes adult patients aged 18 years and older who were diagnosed with type 2 diabetes mellitus. The population consists of individuals with documented medical records, including diabetes duration, glycemic control data (HbA1c levels), and body composition measurements such as muscle mass assessments. The study also includes a control group of non-diabetic individuals matched by age and sex to enable comparative analysis.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults aged 18 years and older.\n2. Diagnosed with type 2 diabetes mellitus according to recognized diagnostic criteria.\n3. Availability of complete body composition data (e.g., DXA measurements).\n4. Documented HbA1c levels and other glycemic control data.\n5. Continuous medical records available during the study period\n\nExclusion Criteria:\n\n1. Presence of other severe metabolic diseases, such as liver failure or kidney failure.\n2. Use of medications affecting muscle mass (e.g., glucocorticoids) for more than three months.\n3. History of malignancy or ongoing treatment for cancer.\n4. Missing critical research data (e.g., diabetes duration or HbA1c levels).\n5. History of surgeries causing significant body composition changes (e.g., bariatric surgery).'}, 'identificationModule': {'nctId': 'NCT06724068', 'briefTitle': 'Diabetes, Insulin Resistance and Body Composition', 'organization': {'class': 'OTHER', 'fullName': 'Qianfoshan Hospital'}, 'officialTitle': 'The Correlation Between Diabetes, Insulin Resistance and Body Composition', 'orgStudyIdInfo': {'id': 'S1181'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetes', 'interventionNames': ['Other: Diabetes，Insulin resistance，Control']}, {'label': 'Insulin resistance', 'interventionNames': ['Other: Diabetes，Insulin resistance，Control']}, {'label': 'Control', 'interventionNames': ['Other: Diabetes，Insulin resistance，Control']}], 'interventions': [{'name': 'Diabetes，Insulin resistance，Control', 'type': 'OTHER', 'description': 'This retrospective study uses medical records and diagnostic data from patients with type 2 diabetes and healthy controls obtained from Qianfoshan Hospital from2019 to 2022', 'armGroupLabels': ['Control', 'Diabetes', 'Insulin resistance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250000', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Shandong First Medical University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'overallOfficials': [{'name': 'Song Xuan, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shandong First Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuan Song', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Xuan Song', 'investigatorAffiliation': 'Qianfoshan Hospital'}}}}