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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03682016
Other study ID # Assiut 93
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 1, 2018
Est. completion date March 1, 2020

Study information

Verified date September 2018
Source Assiut University
Contact Lobna F el toni, prof
Phone 01009673113
Email leltoni@yahoo.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date March 1, 2020
Est. primary completion date April 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 60 Years
Eligibility 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 .

Study Design


Related Conditions & MeSH terms

  • Central Blood Pressure in Diabetic Hypertensive

Locations

Country Name City State
Egypt Assiut Univrtsity Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary relation between central systolic blood pressure and the risk of chronic illnesses. With comparable brachial blood pressure ,Do patients with significantly higher central systolic blood pressure have higher risks to have cardiovascular, peripheral arterial and cerebrovascular diseases or not ? 2 years