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Clinical Trial Details

Trial ID: L6861
Source ID: NCT03804411
Associated Drug: Automatic System Guided Treatment
Title: Prognostic Predictors of Response to Hypoglycemic Therapy
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Automatic system guided treatment|DRUG: Standard treatment
Outcome Measures: Primary: HbA1c, Change from baseline in HbA1c level (%), baseline and 3, 12, and 24 months after intervention|Body mass index, Change from baseline in body mass index (kg/m\^2), baseline and 3, 12, and 24 months after intervention | Secondary: Estimated glomerular filtration rate, Change from baseline in level of estimated glomerular filtration rate (ml/min/1.73 m\^2), baseline, 12 and 24 months after intervention|HOMA-IR index, Change from baseline in level of HOMA-IR index (Homeostasis Model Assessment of Insulin Resistance) derived from the plasma insulin level (mIU/L) and plasma glucose level (mmol/L) of a participant: \[(plasma insulin level) x (plasma glucose level)\]/22.5, where the value of HOMA-IR index \> 2.0 suggests insulin resistance, baseline, 6 and 12 months after intervention|Urinary creatinine-adjusted excretion of albumin, Change from baseline in level of urinary creatinine-adjusted excretion of albumin in morning spot urine samples (mg/mmol), baseline, 12 and 24 months after intervention|Cardiovascular parameters of PAT and IMT, Change from baseline in peripheral arterial tone by using EndoPAT 2000, the thickness of intima-media complex of carotid arteries (μm), baseline, 6 and 12 months after intervention|LDL cholesterol, Change from baseline in level of LDL cholesterol (mmol/L), baseline, 6 and 12 months after intervention|Triglycerides, Change from baseline in level of triglycerides (mmol/L), baseline, 6 and 12 months after intervention|NT-proBNP, Change from baseline in serum level of NT-proBNP (pmol/L), baseline, 6 and 12 months after intervention|hsCRP, Change from baseline in serum level of hsCRP ( mg/L), baseline, 6 and 12 months after intervention|PAT, Change from baseline in peripheral arterial tone by using EndoPAT 2000 (Ratio is created using the post and pre occlusion values), baseline, 6 and 12 months after intervention|IMT, Change from baseline in the thickness of intima-media complex of carotid arteries (μm), baseline, 6 and 12 months after intervention|LV ejection fraction, Change from baseline in ejection fraction (%) by echocardiography, baseline, 6 and 12 months after intervention|LV mass index, Change from baseline in LV mass index (g/m\^2) by echocardiography, baseline, 6 and 12 months after intervention|GLS by 2D-STE, Change from baseline in global longitudinal strain by 2D Speckle-tracking echocardiography (%), baseline, 6 and 12 months after intervention|Molecular-genetic markers of endothelial damage, Change from baseline in serum level of microRNA-126, microRNA-21, microRNA-27, miRNA-125 and miRoRNA-155 (relative units), baseline, 6 and 12 months after intervention
Sponsor/Collaborators: Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 800
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2017-08-01
Completion Date: 2020-05
Results First Posted:
Last Update Posted: 2020-02-10
Locations: Alina Babenko, Saint-Petersburg, 197143, Russian Federation
URL: https://clinicaltrials.gov/show/NCT03804411