Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-27 @ 11:18 PM
Study NCT ID:
NCT05370560
Status:
COMPLETED
Last Update Posted:
2022-05-11
First Post:
2022-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plasma Transthyretin Levels and Risk of Type 2 Diabetes Mellitus and Impaired Glucose Regulation
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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3325}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-07', 'studyFirstSubmitDate': '2022-05-07', 'studyFirstSubmitQcDate': '2022-05-07', 'lastUpdatePostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Type 2 diabetes mellitus', 'timeFrame': 'From December 2010 to December 2016', 'description': 'In the case-control study, type 2 diabetes mellitus was diagnosed in accordance with the diagnostic criteria recommended by WHO in 1999.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transthyretin', 'type 2 diabetes', 'impaired glucose regulation'], 'conditions': ['Type 2 Diabetes', 'Impaired Glucose Regulation']}, 'descriptionModule': {'briefSummary': 'Objective: To investigate the association between plasma transthyretin levels and risk of newly diagnosed type 2 diabetes mellitus (T2DM) and impaired glucose regulation (IGR) in a Chinese population.\n\nDesign: We performed a case-control study, including 1,244 newly diagnosed T2DM patients, 837 newly diagnosed IGR patients, and 1,244 individuals with normal glucose tolerance (NGT). The diagnostic criteria were recommended by World Health Organization in 1999. All cases were recruited from patients who, for the first time, received a diagnosis of T2DM in the Department of Endocrinology, Tongji Hospital, Tongji Medical College, Wuhan, China, from December 2010 to December 2016. Concomitantly, general population undergoing a routine health checkup in the same hospital were enrolled as controls. The inclusion criteria were age ≥ 30 years, BMI \\< 40 kg/m2, and no history of diagnosis of diabetes or receiving pharmacological treatment for hypertension and hyperlipidemia. Participants with clinically significant neurological, endocrinological, psychological or other systemic diseases, as well as acute illness or chronic inflammatory or infectious diseases, were excluded from the present study. Written informed consent was obtained from each participant. Besides, cases were stringently matched to controls in a 1:1 ratio, based on sex and age (± 3 years). All participants enrolled were of Han ethnicity, and gave a commitment of taking no medication known affecting glucose tolerance or insulin secretion before participating in the study. Fasting blood samples were collected in EDTA-anticoagulative tubes and separated for plasma within 1 h. Then plasma was kept at -80℃ prior to analyses. Plasma transthyretin levels were measured by BS 200 Autoanalyser (Mindray, Shenzhen, China) using immunoturbidimetric method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '82 Years', 'minimumAge': '24 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All the participants enrolled were of Chinese Han ethnicity. They gave informed written consent to the study and did not take any medication known to affect glucose tolerance or insulin secretion before participation.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 30 years, BMI \\< 40 kg/m2, and no history of diagnosis of diabetes or receiving pharmacological treatment for hypertension and hyperlipidemia\n\nExclusion Criteria:\n\n* Clinically significant neurological, endocrinological, psychological or other systemic diseases, as well as acute illness or chronic inflammatory or infectious diseases.\n\nIncomplete basic information.'}, 'identificationModule': {'nctId': 'NCT05370560', 'briefTitle': 'Plasma Transthyretin Levels and Risk of Type 2 Diabetes Mellitus and Impaired Glucose Regulation', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'Plasma Transthyretin Levels and Risk of Type 2 Diabetes Mellitus and Impaired Glucose Regulation in a Chinese Population', 'orgStudyIdInfo': {'id': 'YR202205'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Type 2 diabetes mellitus', 'description': 'In this case-control study, T2DM was diagnosed according to the diagnostic criteria recommended by the WHO in 1999. T2DM was confirmed when fasting plasma glucose (FPG) ≥ 7.0 mmol/L and/or 2-h post-glucose load (OGTT2h) ≥ 11.1 mmol/L.', 'interventionNames': ['Other: Plasma transthyretin concentration']}, {'label': 'Impaired glucose regulation', 'description': 'In this case-control study, IGR was diagnosed according to the diagnostic criteria recommended by the WHO in 1999. IGR was defined as impaired fasting glucose (\\[FPG\\] ≥ 6.1 mmol/L and \\< 7.0 mmol/L, and \\[OGTT2h\\] \\< 7.8 mmol/L) and/or impaired glucose tolerance (FPG \\< 7.0 mmol/L, and OGTT2h ≥ 7.8 mmol/L and \\< 11.1 mmol/L).', 'interventionNames': ['Other: Plasma transthyretin concentration']}, {'label': 'Control', 'description': 'Those with FPG \\< 6.1 mmol/L and OGTT2h \\< 7.8 mmol/L were considered controls.', 'interventionNames': ['Other: Plasma transthyretin concentration']}], 'interventions': [{'name': 'Plasma transthyretin concentration', 'type': 'OTHER', 'description': 'Plasma transthyretin concentrations were measured by BS 200 Autoanalyser (Mindray, Shenzhen, China) using immunoturbidimetric method.', 'armGroupLabels': ['Control', 'Impaired glucose regulation', 'Type 2 diabetes mellitus']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liegang Liu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Liegang Liu', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}