The Association Between Serum β-hydroxybutyrate and Levels of Systemic Hypertension
BHB-RCT
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
In this research the investigators are looking for the direct relationship between Beta-hydroxybutyrate and hypertension. Since recent research showed a connection between exercise and hypertension, and diet control and hypertension. The investigators are studying the possible effect of beta-hydroxybutyrate levels on blood pressure control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2020
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2020
CompletedFirst Posted
Study publicly available on registry
April 2, 2020
CompletedStudy Start
First participant enrolled
April 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2020
CompletedApril 2, 2020
April 1, 2020
5 months
January 20, 2020
April 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
scanning for levels of circulating βHB mmol/L in the serum of the participant
scanning for levels of circulating βHB in mmol/L in the serum of the hypertensive arm in comparison to the control arm.
1 week
Secondary Outcomes (2)
The correlation between the salt intake restriction and it is effect on the blood pressure in (mmHg) .
2 weeks
The effect of salt intake (restriction) on the serum level of βHB mmol/L.
2 weeks
Study Arms (3)
normotensive control group
NO INTERVENTIONNormotensive volunteer
hypertensive control group
NO INTERVENTIONHypertensive patients with no restriction on their salt intake
hypertensive interventional group
EXPERIMENTALintervention is going to be salt restriction
Interventions
salt restriction for one week after being diagnosed with hypertension
Eligibility Criteria
You may qualify if:
- All patients ≥ 18 years
- not diagnosed with systemic hypertension
- All patients ≥ 18 years
- First time diagnosed as a case of systemic hypertension
You may not qualify if:
- Diabetes mellitus.
- Previous heart diseases, kidney or liver diseases as these conditions may interfere with the serum levels of β-hydroxybutyrate.
- Patients using diuretics.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hossam Sherif, MD
Sulaiman AlRajhi Colleges
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2020
First Posted
April 2, 2020
Study Start
April 15, 2020
Primary Completion
September 1, 2020
Study Completion
December 28, 2020
Last Updated
April 2, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share