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Clinical Trial Details

Trial ID: L4706
Source ID: NCT03871621
Associated Drug: Diabetes Medicines
Title: Left Ventricular Functional Changes of Uncontrolled Diabetes by Dapagliflozin Treatment Trial
Acronym: ELUCIDATE
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Diabetes Medicines|DRUG: Dapagliflozin
Outcome Measures: Primary: Cardiac global longitudinal strain (GLS), The primary outcome is to measure the change in cardiac GLS from baseline to 6 months after dapagliflozin treatment compared to standard diabetes care., Baseline to Week 24|Left ventricular mass index, The primary outcome is to measure the change in LVMi from baseline to 6 months, Baseline to Week 24 | Secondary: Anthropometric measures by body mass index (BMI), Body weight in kilograms, body height in meters Body weight and height will be combined to report BMI in kg/m\^2 Compare the change in anthropometric measures from baseline to 6 months, Baseline to Week 24|Blood pressure, Change in SBP/DBP level (mmHg) over 24 weeks, Baseline to Week 24|HbA1c, Change in HbA1c (%) by echocardiographic measurement over 24 weeks, Baseline to Week 24|Fasting glucose, Change in fasting glucose level over 24 weeks, Baseline to Week 24|Homeostatic Model Assessment of Insulin Resistance, HOMA-IR, Change in HOMA-IR over 24 weeks, Baseline to Week 24|Plasma biomarker: N-terminal pro-brain natriuretic peptide (NTproBNP), Change of NT-proBNP level (pg/mL) over 24 weeks, Baseline to Week 24|transforming growth factor beta 1 (TGF-β1), Change of TGF-β1 level (μg/L) over 24 weeks, Baseline to Week 24|Plasma biomarker: Growth differentiation factor-15 (GDF-15), Change of GDF-15 level (ng/L) over 24 weeks, Baseline to Week 24|tumor necrosis factor receptor I (TNF-RI), Change of TNF-RI level (ng/mL) over 24 weeks, Baseline to Week 24|Plasma biomarker: fatty acid binding protein 4 (FABP-4), Change of FABP-4 level (IU/mL) over 24 weeks, Baseline to Week 24
Sponsor/Collaborators: Sponsor: Mackay Memorial Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 76
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-04-01
Completion Date: 2022-08-31
Results First Posted:
Last Update Posted: 2023-03-22
Locations: Mackay Memorial Hospital, Taipei, Taiwan
URL: https://clinicaltrials.gov/show/NCT03871621