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Clinical Trial Details

Trial ID: L6920
Source ID: NCT04057261
Associated Drug: Liraglutide Pen Injector [Victoza]
Title: Effect of Liraglutide on the Metabolic Profile in Patients With Type 2 Diabetes and Cardiovascular Disease
Acronym: Lirabolic
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes|Cardiovascular Diseases
Interventions: DRUG: Liraglutide Pen Injector [Victoza]|DRUG: Placebo
Outcome Measures: Primary: Changes in the metabolomics profile (fold changes) between Liraglutide treatment group and placebo group after 1 and 3 months, Changes in the metabolomics profile (fold changes) between Liraglutide treatment group and placebo group after 1 and 3 months measured by a platform including 2 separate reverse phase (RP)/UPLC-MS/MS with positive ion mode electrospray ionization (ESI), (RP)/UPLC-MS/MS with negative ESI, and (HILIC)/UPLC-MS/MS with negative ESI., 3 month | Secondary: change in left ventricular diastolic function, change in left ventricular diastolic function between baseline and after 12 weeks as determined by 2D and 3D parameter global Strain Rate E by echocardiography, 3 month|change in left ventricular diastolic function, change in left ventricular diastolic function between baseline and after 12 weeks as determined by standardized parameter E/é and left atrial (LA) volume by echocardiography, 3 month|change in left ventricular systolic function, change in left ventricular systolic function by ejection fraction (EF) by echocardiography, 3 month|Changes in systolic and diastolic blood pressure (mmHg), Changes in systolic and diastolic blood pressure (mmHg) between Liraglutide treatment group and placebo group after 1 and 3 months., 3 month|body weight, 3 month|Changes in NT-proBNP serum levels (pg/ml), Changes in NT-proBNP serum levels (pg/ml) between Liraglutide treatment group versus placebo group after 1 and 3 months., 3 month|Differences of the serum lipid profile between Liraglutide treatment group and placebo group, Differences of the serum lipid profile including serum levels of triglycerides (mg/dl), total cholesterol (mg/dl), low-density lipoprotein cholesterol (mg/dl) and high-density lipoprotein cholesterol (mg/dl)between Liraglutide treatment group and placebo group after 1 and 3 months, 3 month|changes of serum levels of glucose, HbA1c, glucagon, insulin, C-Peptide, β-Hydroxybutyrate between Liraglutide treatment group and placebo group, Changes in serum levels of glucose (mg/dl), HbA1c (%), glucagon (pg/ml), insulin (ng/ml), C-Peptide (ng/ml), β-Hydroxybutyrate (mmol/l) between Liraglutide treatment group and placebo group after 1 and 3 months, 3 month|Heart rate variability, Differences in heart rate variability measured by 24 hour ECG between Liraglutide treatment group and placebo group after 3 month including the following parameters: mean heart rate (bpm), maximum/minimum heart rate (bpm) and long-term variation of RR intervals (defined as standard deviation over 24 hours of per-minute means of RR intervals)., 3 month|Resting energy expenditure, Resting energy expenditure measured by indirect calorimetry \[CardioCoach CO2\], 3 month|Respiratory Exchange Ratio, Respiratory Exchange Ratio measured by indirect calorimetry \[CardioCoach CO2\], 3 month|Differences in gut microbiome composition measured by 16S rRNA targeted gene sequencing of feces between Liraglutide treatment group and placebo group, Differences in gut microbiome composition measured by 16S rRNA targeted gene sequencing of feces between Liraglutide treatment group and placebo group after 1 and 3 month including the following parameters: alpha diversity (reported as Shannon diversity index) and differences in bacterial composition at different taxonomic levels including genus, family and class of bacteria (reported as relative abundance)., 3 month|Albumin excretion, Albumin excretion by 24 h urine collection, 3 month|changes in inflammasome analyses, Differences in serum levels of inflammatory cytokines including C-reactive protein (mg/ml), Interleukin 6 (pg/ml), Interleukin 1 beta (pg/ml) and tumor necrosis factor alpha (pg/ml) between Liraglutide treatment group and placebo group after 1 and 3 month, 3 month|Differences in circulation inflammatory cell composition by flow cytometry analyses (FACS) between Liraglutide treatment group and placebo group, Differences in circulation inflammatory cell composition by flow cytometry analyses (FACS) between Liraglutide treatment group and placebo group after 1 and 3 month including the following parameters: Numbers of T-cells including T-cell subsets and monocytes including monocyte subsets. Numbers will be reported as percentage of parent, i.e. total pool of CD45+ immune cells)., 3 month
Sponsor/Collaborators: Sponsor: RWTH Aachen University | Collaborators: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2020-11
Completion Date: 2022-11
Results First Posted:
Last Update Posted: 2021-03-10
Locations: Department of Internal Medicine I, University Hospital, Aachen, 52074, Germany
URL: https://clinicaltrials.gov/show/NCT04057261