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Clinical Trial Details

Trial ID: L6566
Source ID: NCT02350478
Associated Drug: Linagliptin
Title: Effects of Linagliptin on Endothelial Function
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02350478/results
Conditions: Type 2 Diabetes|Coronary Artery Disease
Interventions: DRUG: Linagliptin|DRUG: Placebo
Outcome Measures: Primary: Changes in Endothelial Function (FMD - Flow Mediated Dilatation) From Baseline to 12 Weeks, Endothelium-dependent FMD following reactive hyperaemia was examined in the brachial artery according to the guidelines described by Coretti et al (J Am Coll Cardiol. 2002;39(2):257-65). FMD-diameter is calculated as the average of the three diameter measurements following reactive hyperaemia. FMD was calculated as the percent change in diameter compared to baseline. Flow-mediated dilation is reported such as "percentage of change in diameter (%)"., 12 weeks | Secondary: Changes in Global Arginine Bioavailability Ratio (Ratio of Arginine to [Ornithine + Citrulline]) and Arginine to Ornithine Ratio From Baseline to 12 Weeks, Arginine, ornithine and citrulline will be measured in serum samples with a conventional usual amino acid analysis technique, involving separation of amino acids by ion exchange chromatography followed by postcolumn continuous reaction with ninhydrin. Global arginine bioavailability ratio (GABR) will be calculated by L-arginine divided by the sum of (L-ornithine plus L-citrulline). The arginine to ornithine ratio will be calculated by dividing L-arginine by L-ornithine levels., 12 weeks|Changes in Biochemical Markers (sICAM-1), Soluble cell adhesion molecules-1 (sICAM-1) of endothelial function from baseline to 12 weeks, 12 weeks|Changes in the Area Under Curve (AUC) of Glucose, Insulin and C-peptide During the Meal Tolerance Test From Baseline to 12 Weeks, The Area under the curve was calculated for glucose, insulin and for the free fatty acids based on the trapezoidal rule with baseline value as the mean of the values at time points -5 and 0 minutes. The Meal Tolerance Test (MTT) was performed after an overnight fast (apart from water). A pre-meal blood sample will be taken (-5mins) and then all subjects will be asked to drink Fortimel compact (10 kcal/kg) over a period of 2-4 mins (time 0 mins). During the mixed meal test further blood samples will be taken at 15, 30, 60, and 120 minutes. All samples will be used for the determination of glucose, insulin and free fatty acids. The blood at each time point will be placed into a fluoride oxalate tube (1ml) for plasma glucose and into a serum tube for insulin and free fatty acids., 12 weeks|Changes in the Area Under Curve (AUC) of Free Fatty Acids During the Meal Tolerance Test From Baseline to 12 Weeks, The Area under the curve was calculated for glucose, insulin and for the free fatty acids based on the trapezoidal rule with baseline value as the mean of the values at time points -5 and 0 minutes. The MTT was performed after an overnight fast (apart from water). A pre-meal blood sample will be taken (-5mins) and then all subjects will be asked to drink Fortimel compact (10 kcal/kg) over a period of 2-4 mins (time 0 mins). During the mixed meal test further blood samples will be taken at 15, 30, 60, and 120 minutes. All samples will be used for the determination of glucose, insulin and free fatty acids. The blood at each time point will be placed into a fluoride oxalate tube (1ml) for plasma glucose and into a serum tube for insulin and free fatty acids., 12 weeks|Changes in Biochemical Markers (svCAM-1), Soluble cell adhesion molecules-1 (svCAM-1) of endothelial function from baseline to 12 weeks, 12 weeks
Sponsor/Collaborators: Sponsor: Medical University of Graz
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 49
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2013-07
Completion Date: 2017-03
Results First Posted: 2019-12-16
Last Update Posted: 2020-05-15
Locations: Medical University of Graz, Department for Internal Medicine, Graz, 8036, Austria
URL: https://clinicaltrials.gov/show/NCT02350478