Type 2 Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to assess the effects of incretin-based antidiabetic therapies (DPP-4 inhibitors and GLP-1 agonists) on cardiovascular, gastrointestinal and renal system and to detail the mechanisms underlying their action in these systems.
Interventions
DRUGExenatide
DRUGLinagliptin
DRUGGliclazide
Sponsors
Charles University, Czech Republic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes mellitus * Metformin monotherapy - stable dose during last 3 months * HbA1C 48-75 mmol/mol (IFCC) * BMI 25-40 kg/m2 * Age 35-70 years (women postmenopausal) * Use of ACE inhibitors or ATII receptor blockers for at least 3 months before enrollment
Exclusion criteria
* eGFR\<30 ml/min/1.73m2 (MDRD) * Treatment with incretin mimetics during 3 months before enrollment * Chronic insulin therapy * Chronic use of loop diuretics, glucocorticoids, NSAID, immune suppressants, antimicrobial agents, chemotherapeutics, bile acid sequestrants (colestyramin, colesevelam) * History of pancreatic disease or impaired pancreatic function (defined as the need to use pancreatic enzymes) * Active liver disease or a 3-fold elevation of liver transaminases (ALT, AST) * Active malignancy * History of severe cardiovascular disease including acute coronary syndrome, stroke or transient ischemic neurologic disorder during previous 6 months, atrial fibrillation or other arrhythmia requiring chronic antiarrhythmic medication, chronic heart failure (New York Heart Association grade III/IV) * History of alcohol abuse, defined as \>4 units of alcohol/day (32 g or 40 ml of 100% alcohol) * History of allergy for GLP-1 receptor agonists or DPP-4 inhibitors * Any disease that could interfere with study procedures (e.g. decreased mobility, mental incapacity) * Inability to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | 90 days after treatment initiation | — |
| Gastric evacuation velocity | 90 days after treatment initiation | — |
| Blood pressure | 90 days after treatment initiation | — |
| Left ventricular ejection fraction | 90 days after treatment initiation | — |
| Intimomedial thickness | 90 days after treatment initiation | — |
| Pulse wave velocity | 90 days after treatment initiation | — |
| Glomerular filtration rate | 90 days after treatment initiation | — |
| Tubular function | 90 days after treatment initiation | — |
| KIM-1 | 90 days after treatment initiation | Marker of renal damage |
| Exocrine pancreas function | 90 days after treatment initiation | — |
Countries
Czechia
Outcome results
None listed