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

February 27, 2024 updated by: Pr. Semir Nouira, University of Monastir
Included participants who have a stable HT who intend to practice RJ

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Monastir, Tunisia, 5000
        • Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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-patient clinic (Cardiology, Endocrinology) at the emergency department of Fattouma Bourguiba university hospital after a clarified written consent.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure Variability
Time Frame: 60 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Monastir

Investigators

  • Principal Investigator: Semir Nouira, Professor, University of Monastir

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

November 26, 2021

First Submitted That Met QC Criteria

November 26, 2021

First Posted (Actual)

December 9, 2021

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • variability of blood pressure

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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