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Clinical Trial Details

Trial ID: L4412
Source ID: NCT01744236
Associated Drug: Liraglutide
Title: SAFEGUARD: Pleiotropic Effects of Incretin Based Therapies
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Liraglutide|DRUG: Sitagliptin|DRUG: Exenatide|DRUG: Liraglutide placebo|DRUG: Sitagliptin placebo|DRUG: Exenatide placebo|DRUG: L-NMMA
Outcome Measures: Primary: Changes from baseline following infusion of GLP-1RA (acute effects) and the changes from baseline following 12-week treatment with GLP-1RA or DPP-4i (long-term effects) on resting heart rate variability, as derived from electrocardiographic measurements., 12 weeks|Changes from baseline following infusion of GLP-1RA (acute effects) and the changes from baseline following 12-week treatment with GLP-1RA or DPP-4i (long-term effects) on Glomerular Filtration Rate, measured by the inulin-clearance technique., 12 weeks|Changes from baseline following 12-week treatment with GLP-1RA or DPP-4i (long-term effects) on pancreatic exocrine function, measured as fecal Elastase-1., 12 weeks | Secondary: Changes from baseline following infusion of GLP-1RA (acute effects) and the changes from baseline following 12-week treatment with GLP-1RA or DPP-4i (long-term effects) on the following cardiovascular parameters:, * Blood pressure and heart rate * Hemodynamic variables (blood pressure, heart rate, stroke volume, cardiac output/-index/-contractility, systemic vascular resistance) derived from non-invasive beat-to-beat finger blood pressure measurements * Cardiac autonomic nervous system function * Microvascular function and vasomotion * Arterial stiffness * Lipid spectrum * Glycemic variables (HbA1c, fasting and postprandial glucose) * Body anthropometrics: body weight, height, BMI and waist circumference * Body fat content, 12 weeks|Changes from baseline following infusion of GLP-1RA (acute effects) and the changes from baseline following 12-week treatment with GLP-1RA or DPP-4i (long-term effects) on the following renal parameters:, * Effective renal plasma flow (ERPF) * Renal tubular function * Renal damage, measured by urine biomarkers, 12 weeks|Changes from baseline following infusion of GLP-1RA (acute effects*) and changes from baseline following 12-week treatment with GLP-1RA or DPP-4i (long-term effects) on the following gastrointestinal parameters:, * Pancreatic exocrine function (\* In the acute intervention only exocrine pancreatic function is assessed) * Pancreatic structure * Pancreatic enzymes * Gallbladder emptying speed * Liver enzymes * Hepatic structure/steatosis * Gastric emptying, 12 weeks
Sponsor/Collaborators: Sponsor: Amsterdam UMC, location VUmc | Collaborators: EU FP7: SAFEGUARD consortium
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 70
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2013-04
Completion Date: 2015-08
Results First Posted:
Last Update Posted: 2015-12-09
Locations: VU University Medical Center, Amsterdam, 1081HV, Netherlands
URL: https://clinicaltrials.gov/show/NCT01744236