Effects of Romadan Fasting on Variability in Blood Pressu... | NCT05152043

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

NCT05152043

Sponsor

University of Monastir

Status

Completed

Last Update Posted

Apr 17, 2026Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Hypertension

Interventions

Not provided

Countries

Tunisia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2019Actual

Primary Completion Date

Dec 31, 2024Actual

Completion Date

Dec 31, 2024Actual

First Submitted Date

Nov 26, 2021

First Submission Date that Met QC Criteria

Nov 26, 2021

First Posted Date

Dec 9, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2026

Last Update Posted Date

Apr 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Stable patients with diagnosed hypertension that intend to fast ramadan. Each participant is examined during two planned visits. The first takes place during the month preceding Ramadan. The second during the last week 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patient with diagnosed hypertension intending to fast Ramadan.

Exclusion Criteria :

Age < 30 years old
Adult patient with or without diagnosed hypertension not intending to fast Ramadan.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Stable patients with or without diagnosed hypertension that intend to fast ramadan. Each participant is examined during two planned visits. The first takes place during the month preceding Ramadan. The second during the last week 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Semir Nouira, Professor	University of Monastir	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia		Monastir		5000	Tunisia

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided