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

NCT04948086 | Completed

• 1 other identifier: REC/11/0081 Obs
• Study Type: observational
• Target: 498
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Keywords

Blood Pressure; MTHFR; Methylenetetrahydrofolate Reductase; Central Hemodynamics; Riboflavin; Folic Acid; Folate Polymorphism

Outcome Measures

Primary Outcomes (1)

• Blood pressure

  Office blood pressure

  One day, one measurement

Secondary Outcomes (9)

• Brachial blood pressure

  One day, one measurement

• Central blood pressure

  One day, one measurement

• Pulse wave analysis

  One day, one measurement

• Pulse wave velocity

  One day, one measurement

• Riboflavin status

  One day, one measurement

Study Arms (2)

TT MTHFR genotype

Non-TT (i.e. CC/CT) MTHFR genotype

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community sample

You may qualify if:

• Pre-screened for MTHFR 677TT genotype
• Aged at least 18 years old

You may not qualify if:

• Younger than 18 years
• Pregnant

Sponsors & Collaborators

• University of Ulster: lead

Study Sites (1)

Human Intervention Studies Unit, Ulster University

Coleraine, Co.Londonderry, BT52 1SA, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, washed red cells, whole blood, whole blood in ascorbic acid (1 in 10 dilution), buffy coat.

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: July 1, 2021
• Study Start: June 28, 2011
• Primary Completion: August 15, 2019
• Study Completion: August 15, 2019
• Last Updated: July 1, 2021

Record last verified: 2021-06

Locations

GB (1)