Clinical trial NCT03682016: The Effect of Central Blood Pressure on Clinical Outcome in Diabetic Hypertensive Patients in Assiut University Hospitals
Official title: The Effect of Central Blood Pressure on Clinical Outcome in Diabetic Hypertensive Patients in Assiut University Hospitals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Central Blood Pressure in Diabetic Hypertensive
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 150 patients attending internal medicine clinics in Assiut University Hospitals

Brief summary: In recent decades, some observational studies suggest that peripheral BP measured by brachial artery may not necessarily represent BP measured in the aortic artery which is known as central BP .In addition, some clinical trials also revealed that despite with comparable peripheral BP, patients with high central BP had significantly higher cardiovascular risk compared with those with low central BP indicating that central BP might be an independent predictor for CVD

Detailed description: Diabetes mellitus (DM) is amajor risk factor for cardiovascular and renal diseases\[1\] .It is known about two thirds of diabetic patients died from these complication .Numerous epidemiological studies demonstrate that DM is commonly accompanied with hypertension and patients with diabetes and hypertension have higher renal and cardiovascular risks compared with those with either hypertension or diabetes. Therefore, better evaluating and managing BP in diabetic patients with hypertension is clinically relevant.

Hypertension also is a major risk factor for cardiovascular diseases (CVD) and all-cause mortality . Numerous randomized controlled trials using antihypertensive drugs and meta-analysis demonstrate that lowering peripheral blood pressure (BP) is beneficial for reducing cardiovascular and renal events.

In recent decades, some observational studies suggest that peripheral BP measured by brachial artery may not necessarily represent BP measured in the aortic artery which is known as central BP.

In addition, some clinical trials also revealed that despite with comparable peripheral BP, patients with high central BP had significantly higher cardiovascular risk compared with those with low central BP indicating that central BP might be an independent predictor for CVD

Eligibility criteria: Inclusion Criteria:

* Patients aged 40 - 60 years old
* Patients in group A and B are documented to have type 2 DM
* Patients in group A are documented to have essential hypertension .
* Hypertensive patients enrolled must be compliant on their treatment for at least one month

Exclusion Criteria:

* Pregnancy or breastfeeding .
* Concomitant therapy of digoxin, lithium, non-depolarizing skeletal muscle relaxants, sex hormone .
* Documented rheumatic diseases such as systemic lupus erythematosus .

Primary outcomes:
measure: relation between central systolic blood pressure and the risk of chronic illnesses.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Univrtsity
Study officials:
References: