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Clinical Trial Details

Trial ID: L4588
Source ID: NCT01761318
Associated Drug: Liraglutide
Title: Effect of Liraglutide on Cardiovascular Endpoints in Diabetes Mellitus Type 2 Patients
Acronym: MAGNA VICTORIA
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus Type 2|Metabolic Syndrome|Cardiovascular Disease|Diastolic Dysfunction|Fatty Liver
Interventions: DRUG: Liraglutide|DRUG: Liraglutide - Placebo
Outcome Measures: Primary: Stroke volume, Change from baseline in ml: difference between groups, 0 and 26 weeks|Ejection Fraction, Change from baseline in percentage: difference between groups, 0 and 26 weeks|Cardiac output, Change from baseline in L/min: difference between groups, 0 and 26 weeks|Cardiac index, Change from baseline in L/min/m2: difference between groups, 0 and 26 weeks|Peak ejection rate, Change from baseline in ml end-diastolic volume/sec: difference between groups, 0 and 26 weeks|Early peak filling rate, Change from baseline in ml end-diastolic volume/sec: difference between groups, 0 and 26 weeks|Early deceleration peak, Change from baseline in ml/sec: difference between groups, 0 and 26 weeks|Atrial peak filling rate, Change from baseline in ml/sec: difference between groups, 0 and 26 weeks|Early deceleration peak / Atrial peak filling rate (E/A ratio), Change from baseline of the ratio: difference between groups, 0 and 26 weeks|Peak mitral annulus longitudinal motion, Change from baseline in cm/sec: difference between groups, 0 and 26 weeks|Left ventricular filling pressure (= early peak filling rate / peak mitral annulus longitudinal motion), Change from baseline in mmHg: difference between groups, 0 and 26 weeks | Secondary: Aorta and carotid vessel wall imaging, Change from baseline of total vessel wall area in mm2: difference between groups, 0 and 26 weeks|Aorta and carotid vessel wall imaging, Change from baseline of average vessel wall thickness in mm: difference between groups, 0 and 26 weeks|Aorta and carotid vessel wall imaging, Change from baseline of a minimum vessel wall thickness in mm: difference between groups, 0 and 26 weeks|Aorta and carotid vessel wall imaging, Change from baseline of maximum vessel wall thickness in mm: difference between groups, 0 and 26 weeks|Aorta and carotid vessel wall imaging, Change from baseline of vascular distensibility (pulse wave velocity): difference between groups, 0 and 26 weeks|Adipose tissue distribution, Change from baseline of the ratio subcutaneous fat / visceral abdominal fat: difference between groups, 0 and 26 weeks|Total body fat, Change from baseline of total fat volume in ml: difference between groups, 0 and 26 weeks|Epicardial fat volume, Change from baseline in cm3: difference between groups, 0 and 26 weeks|Magnetic Resonance Spectroscopy of the heart, Change from baseline in percentage: difference between groups, 0 and 26 weeks|Magnetic Resonance Spectroscopy of the liver, Change from baseline in percentage: difference between groups, 0 and 26 weeks|Magnetic Resonance Spectroscopy of the kidney, Change from baseline in percentage: difference between groups, 0 and 26 weeks|HBA1C, Measurements will be used to guide therapeutic management The outcome measure glycemic control will be based on the average HBA1C level of all measurements and regards: difference between groups., 0,8, 12, 16 and 26 weeks|Fasting blood glucose level, Fasting blood glucose levels will be used to guide therapeutic management and for safety reasons. Outcome measure: the difference between groups of the average of all measurements., 0, 4, 8, 12, 16, 20, 26 weeks|Myocardial T1 - mapping, Change from baseline of myocardial T1 - values before and after contrast: difference between groups, 0 and 26 weeks | Other: Anthropometric measurements, Length, body weight and calculated BMI. Outcome measure: Change from baseline in kg (body weight) or kg/m2 (BMI): difference between groups, 0, 4, 8, 12, 16, 20, 26 weeks|Waist / hip ratio, Waist circumference divided by hip circumference. Outcome measure: change from baseline: difference between groups, 0, 4, 8, 12, 16, 20, 26 weeks|Systolic blood pressure, Measurements for routine clinical management Outcome measure: change from baseline in mmHg: difference between groups, 0, 4, 8, 12, 16, 20, 26 weeks|Diastolic blood pressure, Measurements for routine clinical management Outcome measure: change from baseline in mmHg: difference between groups, 0, 4, 8, 12, 16, 20, 26 weeks|Resting Energy Expenditure, Change from baseline: difference between groups Measurement with indirect calorimetry (Jaeger, OxyconPro), 0, 4, 12, 26 weeks|Immunological analysis, Fluorescence-Activated Cell Sorting (FACS). Change from baseline: difference between groups., 0, 26 weeks|Immunological analysis, Peripheral Blood Mononuclear Cell isolation to analyze immunological activation and status of subjects. Both quantification of white blood cells (T-cells, B-cells, macrophages) and functional analysis will be performed. Change from baseline: difference between groups, 0, 26 weeks|Fasting insulin level, Change from baseline: difference between groups, 0 and 26 weeks|Leptin, Change from baseline: difference between groups, 0 and 26 weeks|Glucagon, Change from baseline: difference between groups, 0 and 26 weeks|Adiponectin, Change from baseline: difference between groups, 0 and 26 weeks|CETP, Cholesteryl ester transfer protein Change from baseline: difference between groups, 0, 4, 12 and 26 weeks|High Sensitive C Reactive Protein, Change from baseline: difference between groups, 0, 4, 12 and 26 weeks|Free Fatty Acids, Change from baseline: difference between groups, 0, 4, 12 and 26 weeks|Cholesterol level (total, HDL and LDL), Change from baseline: difference between groups, 0, 4, 12 and 26 weeks|Liver function tests (ALT, AST, AF, GGT), Change from baseline: difference between groups, 0, 4, 12 and 26 weeks|Triglycerides, Change from baseline: difference between groups, 0, 4 , 12 and 26 weeks|QUICKI, Quantitative Insulin Sensitivity Check Index Change from baseline: difference between groups, 0 and 26 weeks|Albuminuria, Change from baseline of urinary albumin / creatinine ration: difference between groups, 0 and 26 weeks|Immunological analysis, Immunological status as assessed by RNA profiling. Change from baseline: difference between groups, 0 and 26 weeks|Metabolomics, Metabolomics in urine and blood sample. Change from baseline: difference between groups, 0 and 26 weeks|Insulin dose, Total daily dose (units) of insulin. Change from baseline: difference between groups, 0 and 26 weeks|Hypoglycaemic episodes, Number of grade 1, 2 and 3 hypoglycaemic episodes as detected with self measurement by participants. Comparison between groups., Between week 0 and 26
Sponsor/Collaborators: Sponsor: Leiden University Medical Center | Collaborators: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 50
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2013-11
Completion Date: 2016-03
Results First Posted:
Last Update Posted: 2016-05-05
Locations: Leiden University Medical Center, Leiden, 2333 ZA, Netherlands
URL: https://clinicaltrials.gov/show/NCT01761318