MedPath

Blood Pressure and Central Haemodynamics in Healthy Adults Stratified by MTHFR Genotype

Completed
Conditions
Blood Pressure
Registration Number
NCT04948086
Lead Sponsor
University of Ulster
Brief Summary

Approximately 12% of the world's population have a have a common C677T polymorphism in the gene encoding the folate metabolising enzyme, methylenetetrahydrofolate reductase (MTHFR). Homozygosity for the polymorphism (TT genotype) appears to result in an increased requirement for the B-vitamins folic acid and riboflavin and more importantly results in an increased risk of developing high blood pressure (BP). Previous work from our Centre has demonstrated significantly higher BP in those with the TT genotype. This work has been conducted in cohorts with premature cardiovascular disease (CVD) and hypertension without overt CVD, but the effect in younger, healthier individuals is unexplored. To date our studies have also focused on BP as the primary outcome, but newer markers of vascular health including central pressure and hemodynamics have emerged as superior prognostic indicators of CVD. The effect of the TT genotype on these measures is thus an important area for investigation and may help us understand the mechanism linking the genotype with BP, which is currently unknown. As adults with the TT genotype appear to have increased requirements for riboflavin and folic acid, and BP in TT adults appears to be riboflavin dependent, the influence of these vitamins on central measures is an area for consideration. Study Design This is an observational study investigating the blood pressure profiles of healthy adults aged 18-65 years, stratified by MTHFR genotype. Apparently healthy adults will be recruited from workplaces and the general community across Northern Ireland and screened for the polymorphism via buccal swab. Those with the TT genotype and a similar number of non-TT (i.e. CC/CT) genotype individuals will be contacted and asked to come to attend a one-off appointment. Brachial BP will be assessed by an electronic BP monitor, central BP and central haemodynamics (augmentation index, augmentation pressure and pulse wave velocity) will be assessed by SphygmoCor XCEL. In addition, anthropometric measurements, health and lifestyle information and a blood sample will be obtained. Data will be statistically analysed using SPSS software to if determine differences between gentoype groups exist.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
498
Inclusion Criteria
  • Pre-screened for MTHFR 677TT genotype
  • Aged at least 18 years old
Exclusion Criteria
  • Younger than 18 years
  • Pregnant

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Blood pressureOne day, one measurement

Office blood pressure

Secondary Outcome Measures
NameTimeMethod
Pulse wave velocityOne day, one measurement

Measured using SphygmoCor device

Brachial blood pressureOne day, one measurement

Measured using SphygmoCor device

Central blood pressureOne day, one measurement

Measured using SphygmoCor device

One-carbon metabolite statusOne day, one measurement

Measured by GCMS-MS

Pulse wave analysisOne day, one measurement

Measured using SphygmoCor device

Folate statusOne day, one measurement

Measured by microbiological assay

PLP statusOne day, one measurement

Measured by HPLC

Homocysteine statusOne day, one measurement

Measured by GCMS

Riboflavin statusOne day, one measurement

Measured by by EGRac

Trial Locations

Locations (1)

Human Intervention Studies Unit, Ulster University

🇬🇧

Coleraine, Co.Londonderry, United Kingdom

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