Status:
TERMINATED
Aldosterone Antagonism and Microvascular Function
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Abdominal Obesity Metabolic Syndrome
Insulin Resistance
Eligibility:
All Genders
40-65 years
Phase:
PHASE4
Brief Summary
The prevalence of obesity and obesity-related complications is currently taking epidemic proportions. These complications increase the risk of type 2 diabetes and cardiovascular disease, which are imp...
Eligibility Criteria
Inclusion
- Age 40-65 years
- Caucasian
- Waist circumference \> 102 cm (men)/\> 88 cm (women)
- Triglycerides \> 1.7 mmol/L
- High-normal blood pressure (office blood pressure: 130/85 - 139/89 mm Hg) or stage I hypertension (office blood pressure: 140/90 mm Hg - 159/99 mm Hg; 24h ABPM: 125/80 - 149/89 mm Hg)
Exclusion
- Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, congestive heart failure, cardiac shunts, cardiac surgery, pulmonary hypertension, cardiac arrhythmias, family history of cardiac arrhythmias or sudden cardiac death)
- Diabetes mellitus/impaired glucose metabolism (fasting glucose values \> 5.6 mmol/L)
- Grade 2 or 3 hypertension (office blood pressure: \> 160/100 mm Hg; ABPM \> 150/90 mm Hg)
- Unstable or severe pulmonary disease
- Unstable or severe thyroid disorders
- Inflammatory diseases
- Alcohol use \> 2 U/day (women)/\> 3 U/day (men)
- Use of antihypertensive, lipid-lowering or glucose-lowering medications,
- Use of corticosteroids, medication known to inhibit or induce CYP3A4, lithium, and tricyclic antidepressants or antipsychotic medication, and regular use (weekly or several times a week) of NSAIDs
- Plasma potassium levels \< 3.2 mmol/L or \> 5 mmol/L
- eGFR \< 60 mL/min
- Impairment of hepatic function
- Pregnancy or lactation
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2018
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01887119
Start Date
October 1 2013
End Date
November 1 2018
Last Update
November 5 2018
Active Locations (1)
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1
Maastricht University
Maastricht, Limburg, Netherlands, 6229 ER