Aldosterone Antagonism and Microvascular Function
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|ClinicalTrials.gov Identifier: NCT01887119|
Recruitment Status : Recruiting
First Posted : June 26, 2013
Last Update Posted : December 5, 2017
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 important causes of morbidity and mortality worldwide.
It is important to gain insight in the mechanisms underlying obesity-related complications, because this may lead to the development of directed therapeutic strategies.
Currently, there is significant evidence that the cause of both insulin resistance and hypertension must be sought at the level of the microcirculation.
Over activity of the renin-angiotensin-aldosterone system is a potential cause of microvascular dysfunction. Angiotensin II was indeed found to be implicated in the pathogenesis of obesity-associated hypertension and insulin resistance, possibly through interference with the vascular effects of insulin.
Increased aldosterone levels have also been associated with resistant hypertension and insulin resistance, which is illustrated in patients with primary aldosteronism. Furthermore, aldosterone is known to exert several detrimental effects on the vasculature, some of which are offset by mineralocorticoid receptor antagonists.
In obese individuals, plasma aldosterone concentrations are increased as well. We hypothesize that increased aldosterone levels in adipose persons induce microvascular dysfunction, which contributes to the development of insulin resistance and hypertension, and mineralocorticoid receptor antagonism results in improved insulin sensitivity and decreased blood pressure by counteracting the adverse effects of aldosterone on the microvasculature.
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Obesity Metabolic Syndrome Insulin Resistance Hypertension||Drug: Eplerenone Other: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Effects of Aldosterone Antagonism on Insulin-mediated Microvascular Function in Subjects With the Metabolic Syndrome|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Eplerenone
Eplerenone 50 mg 1dd during four weeks
Placebo Comparator: Placebo
- Change in capillary recruitment (insulin-induced increase in microvascular blood volume in skeletal muscle) from baseline after 4 weeks of Eplerenone treatment or placebo [ Time Frame: Change from baseline after 4 weeks of treatment with either Eplerenone or placebo ]The difference in microvascular blood volume in skeletal muscle of the forearm, which is assessed with contrast enhanced ultrasound, before and during a hyperinsulinemic, euglycemic clamp (performed to determine insulin sensitivity)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887119
|Contact: Monica Schüttenemail@example.com|
|Maastricht, Limburg, Netherlands, 6229 ER|
|Contact: Monica Schütten firstname.lastname@example.org|
|Principal Investigator:||prof. C.D.A. Stehouwer, MD, PhD||Maastricht University Medical Center|