Cf-PWV and TyG Index Study

NCT07589374 | Not Yet Recruiting DMC

• 1 other identifier: RIGID-TyG
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate how metabolic health is related to arterial stiffness and daily blood pressure patterns. High blood pressure is one of the leading causes of heart disease worldwide, but cardiovascular risk is not determined only by average blood pressure values. Changes in blood vessel structure and metabolic function also play an important role in the development of cardiovascular disease. Arterial stiffness reflects how flexible or rigid the arteries are. It can be measured using carotid-femoral pulse wave velocity (cf-PWV), which is considered a reliable and widely used method to assess vascular health. Increased arterial stiffness is associated with aging and higher cardiovascular risk. At the same time, metabolic factors such as insulin resistance and central obesity are strongly linked to vascular damage. The triglyceride-glucose (TyG) index is a simple measure derived from routine blood tests and has been shown to reflect insulin resistance. Additional derived indices that combine TyG with body measurements (such as waist circumference and body mass index) may provide an even more comprehensive evaluation of metabolic risk. Another important aspect of cardiovascular regulation is how blood pressure changes throughout the day. Blood pressure naturally rises in the morning after waking, a phenomenon known as the morning blood pressure surge. When this increase is excessive, it has been associated with a higher risk of cardiovascular events such as stroke and heart attack. This study will evaluate the relationship between metabolic indices, arterial stiffness, and morning blood pressure patterns in adults undergoing ambulatory blood pressure monitoring as part of routine clinical care. The study will include both previously collected data and new participants evaluated using standardized methods. No additional interventions will be performed, and all data will be collected as part of routine clinical evaluation. The results of this study may help improve cardiovascular risk assessment by integrating simple metabolic markers with vascular measurements and daily blood pressure behavior, potentially allowing earlier identification of individuals at higher risk.

Conditions

Hypertension; Arterial Stiffness; Cardiovascular Risk; Blood Pressure Variability; Insulin Resistance Syndrome

Keywords

Arterial stiffness; Pulse wave velocity; Triglyceride-glucose index; Insulin resistance; Ambulatory blood pressure monitoring; Morning blood pressure surge; Blood pressure variability; Cardiovascular risk

Outcome Measures

Primary Outcomes (1)

• Carotid-femoral pulse wave velocity (cf-PWV)

  Carotid-femoral pulse wave velocity (cf-PWV) will be measured as a marker of arterial stiffness using a validated non-invasive device under standardized conditions. The association between cf-PWV and the triglyceride-glucose (TyG) index will be evaluated.

  Baseline

Secondary Outcomes (4)

• Morning systolic blood pressure

  Average systolic blood pressure during the first two hours after awakening, obtained from 24-hour ambulatory blood pressure monitoring (ABPM).

• Morning diastolic blood pressure

  Average diastolic blood pressure during the first two hours after awakening, obtained from ABPM.

• Sleep-through morning blood pressure surge

  Difference between morning systolic blood pressure and the lowest nocturnal systolic blood pressure value.

• Prewaking morning blood pressure surge

  Difference between morning systolic blood pressure and the average systolic blood pressure during the two hours preceding awakening.

Study Arms (2)

Normotensive participants

Adults with normal 24-hour blood pressure based on ABPM (\< 130/80 mmHg)

Untreated hypertensive participants

Adults with elevated 24-hour blood pressure (≥130/80 mmHg) not receiving antihypertensive treatment.

Eligibility Criteria

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

Study Population

The study population will consist of adults aged 18 to 65 years referred for ambulatory blood pressure monitoring (ABPM) as part of routine clinical evaluation at a specialized cardiovascular center. Participants will include both normotensive individuals and untreated hypertensive individuals, classified based on 24-hour ABPM measurements. The study will include both previously collected data and prospectively recruited participants evaluated using standardized protocols.

You may qualify if:

• Adults aged 18 to 65 years;
• Both sexes;
• Referred for ambulatory blood pressure monitoring (ABPM) as part of routine clinical evaluation;
• Not receiving antihypertensive medication at the time of assessment;
• Availability of valid 24-hour ABPM data;
• Availability of carotid-femoral pulse wave velocity (cf-PWV) measurement;
• Availability of fasting laboratory data, including glucose and triglycerides, for calculation of the triglyceride-glucose (TyG) index;
• Ability and willingness to provide written informed consent (for prospectively recruited participants).

You may not qualify if:

• Use of antihypertensive medication at the time of evaluation;
• Cardiac arrhythmias that may interfere with accurate blood pressure or pulse wave velocity measurements;
• Invalid or poor-quality ambulatory blood pressure monitoring (ABPM) recordings;
• Inability to obtain reliable carotid-femoral pulse wave velocity (cf-PWV) measurements;
• Presence of severe vascular disease or conditions affecting arterial waveform assessment;
• Missing essential clinical, laboratory, or hemodynamic data required for the primary analysis;
• Pregnancy;
• Refusal or inability to provide informed consent (for prospectively recruited participants).

Sponsors & Collaborators

• Hospital de Base: lead

Study Sites (1)

Medicine School of São José do Rio Preto

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Related Publications (27)

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MeSH Terms

Conditions

Hypertension; Metabolic Syndrome; Insulin Resistance

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jose F VILELA-MARTIN, PhD

  Medicine School of São José do Rio Preto - SP - Brazil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco A VIEIRA-da-SILVA, MSc

CONTACT

+55 (34) 99645-0117; vilelamartin@uol.com.br

Marco A de Almeida, MD

CONTACT

+55 (34) 99122-7594; telelo60@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 2, 2026
• First Posted: May 15, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)