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NCT05152043 Clinical Trial

Effects of Romadan Fasting on Variability in Blood Pressure in Healthy and Hypertensive Subjects

Hypertension Clinical Trial

Official title:
Effects of Romadan Fasting on Variability in Blood Pressure in Healthy and Hypertensive Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05152043
Other study ID # variability of blood pressure
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2019
Est. completion date December 31, 2021

Study information
Verified date March 2022
Source University of Monastir
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Included participants who have a stable HT who intend to practice RJ

Description:

Stable patients with or without diagnosed hypertension that intend to fast ramadan. Each participant is examined during three planned visits. The first takes place during the month preceding Ramadan. The second during the last week of Ramadan and the third thirty days after the end of Ramadan. Participants that miss one appointement or more are exluded from the study. Patient recrutement is conducted in primary care centers of the state of Monastir, out-patients clinic (Cardiology, Endocrinology) at the emergency department of Fattouma Bourguiba university hospital after a clarified written consent.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers
Gender All
Age group 30 Years and older
Eligibility Inclusion Criteria: - Adult patient with or without diagnosed hypertension intending to fast Ramadan. Exclusion Criteria : - Age < 30 years old - Adult patient with or without diagnosed hypertension not intending to fast Ramadan.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Tunisia Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia Monastir

Sponsors (1)
Lead Sponsor Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood Pressure Variability Values are registered during 24 hours. Diurnal measures are defined as measures conducted during 6 am and 10 pm, whereas nocturnal measures are defined as those registered during the remaining hours. Mean systolic blood pressure and diastolic blood pressure are calculated for the 24 hours for both diurnal and nocturnal period. 60 days
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