Hypertension Clinical Trial
Official title:
Aldosterone-induced Microvascular Dysfunction as a Cause of Salt-sensitivity in Obesity?
Verified date | May 2017 |
Source | Maastricht University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Currently, the incidence of obesity and obesity-related disorders is reaching epidemic
proportions, which entails an increasing burden for health care systems. The association of
obesity with other risk factors for type 2 diabetes mellitus and cardiovascular disease,
such as insulin resistance and hypertension, is often referred to as the metabolic syndrome.
During recent years, salt-sensitivity of blood pressure has emerged as an additional
cardiovascular risk factor that is related to obesity and other key components of the
metabolic syndrome. The underlying pathophysiological mechanisms of these interrelationships
are complex and incompletely elucidated. Microvascular dysfunction has been proposed as a
link between insulin resistance and hypertension in obese individuals. In addition,
impairment of microvascular function was found to be associated with salt-sensitivity of
blood pressure. Increased aldosterone levels, as observed in obese individuals, might be a
cause of microvascular dysfunction-induced salt-sensitivity and insulin resistance.
Aldosterone not only gives rise to sodium-retention in the distal tubule of the kidney, but
was also found to impair endothelial function and thus lower NO-availability, which is
characteristic of microvascular dysfunction. In addition, elevated aldosterone levels are
associated with both hypertension and insulin resistance, which is illustrated in patients
with primary aldosteronism, but also in the general population.
The investigators hypothesize that increased aldosterone levels in obese individuals lead to
impairment of microvascular function through reduction of NO-availability. This
microvascular dysfunction is suggested to play a central role in the pathogenesis of
salt-sensitive hypertension and insulin resistance.
Status | Completed |
Enrollment | 40 |
Est. completion date | October 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: Obese individuals - Age 18-65 years - Caucasian - Waist circumference > 102 cm (men)/> 88 cm (women) Lean individuals - Age 18-65 years - Caucasian - Waist circumference < 94 cm (men)/< 80 cm (women) Exclusion Criteria: Obese/lean individuals - 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 - Stage 3 hypertension (blood pressure > 180/110 mm Hg) - Unstable or severe pulmonary disease - Unstable or severe thyroid disorders - Inflammatory diseases - Smoking - Alcohol use > 2 U/day (women)/> 3 U/day (men) - Use of antihypertensive, lipid-lowering or glucose-lowering medications - Use of corticosteroids and regular use of NSAIDs - eGFR< 60 mL/min - Impairment of hepatic function - Pregnancy or lactation |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht University | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in capillary recruitment between low- and high sodium diets | One week low-sodium diet; wash-out period of two weeks; one week high-sodium diet; order of respective diets is randomized |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04591808 -
Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia
|
Phase 3 | |
Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
Completed |
NCT05433233 -
Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension
|
N/A | |
Completed |
NCT05491642 -
A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses
|
Phase 1 | |
Completed |
NCT03093532 -
A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT05529147 -
The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
|
||
Recruiting |
NCT05976230 -
Special Drug Use Surveillance of Entresto Tablets (Hypertension)
|
||
Recruiting |
NCT06363097 -
Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
|
||
Completed |
NCT06008015 -
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Recruiting |
NCT05121337 -
Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension
|
N/A | |
Withdrawn |
NCT04922424 -
Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men
|
Phase 1 | |
Active, not recruiting |
NCT05062161 -
Sleep Duration and Blood Pressure During Sleep
|
N/A | |
Completed |
NCT05087290 -
LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
|
||
Not yet recruiting |
NCT05038774 -
Educational Intervention for Hypertension Management
|
N/A | |
Completed |
NCT05621694 -
Exploring Oxytocin Response to Meditative Movement
|
N/A | |
Completed |
NCT05688917 -
Green Coffee Effect on Metabolic Syndrome
|
N/A | |
Recruiting |
NCT05575453 -
OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure
|
N/A |