Clinical trial NCT02092597: Safety Evaluation of Adverse Reactions in Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2014-03-20
Enrollment: 42
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Heart rate
timeFrame: 90 days after treatment initiation
measure: Gastric evacuation velocity
timeFrame: 90 days after treatment initiation
measure: Blood pressure
timeFrame: 90 days after treatment initiation
measure: Left ventricular ejection fraction
timeFrame: 90 days after treatment initiation
measure: Intimomedial thickness
timeFrame: 90 days after treatment initiation
measure: Pulse wave velocity
timeFrame: 90 days after treatment initiation
measure: Glomerular filtration rate
timeFrame: 90 days after treatment initiation
measure: Tubular function
timeFrame: 90 days after treatment initiation
measure: KIM-1
timeFrame: 90 days after treatment initiation
measure: Exocrine pancreas function
timeFrame: 90 days after treatment initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: General University Hospital
Study officials:
affiliation: 3rd Department of Medicine, General University Hospital and Charles University 1st Faculty of Medicine
name: Martin Haluzik, MD DSc
role: PRINCIPAL_INVESTIGATOR
References: