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NCT Number: NCT05522075

Reducing Blood Pressure in Mid-life Adult Binge Drinkers

This study has two phases:

Phase 1 is to examine blood pressure, microvascular function, and sympathetic nerve activity in mid-life adult binge drinkers vs. alcohol abstainers/moderate drinkers.

Phase 2 is to examine the effect of 8-week aerobic exercise training on blood pressure, microvascular function, and sympathetic nerve activity in mid-life adult binge drinkers

Recruiting

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Key information

Age range

50 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas at Arlington

Arlington, Texas, 76010, United States

Location status: Recruiting

Location contact

Chueh-Lung Hwang, PhD, PT

CONTACT

[email protected]

817-272-9722

About this study

During phase 1, we will measure blood pressure, microvascular function, and sympathetic nerve activity (baseline assessment) in mid-life adult binge drinkers, alcohol abstainers, and moderate drinkers. Only mid-life adult binge drinkers will enter Phase 2 and be randomized to the exercise training group and non-exercise control group. After 8 weeks of intervention, we will re-measure blood pressure, microvascular function, and sympathetic nerve activity (post-intervention assessment) in mid-life adult binge drinkers.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women (50-64 years of age) who do not drink alcohol, who drink at moderate levels, or who binge drink
  • Female subjects will be postmenopausal (i.e., cessation of menses for ≥1 yr).
  • Subjects who can speak and understand English.

Exclusion criteria

  • a history of diabetes, cardiovascular disease, liver, or renal disease
  • current or history of smoking and illicit drug use
  • blood pressure ≥160/100 mm Hg
  • other known traditional cardiovascular disease risks: obesity (BMI≥35 kg/m2), or hyperlipidemia (total cholesterol>230 mg/dl and/or LDL cholesterol>160 mg/dl)
  • active infection (in the past 2 months)
  • a history of seizures, cancer, or inflammatory disease (i.e., gout or rheumatoid)
  • unstable body weight (>5% change during the past 6 months)
  • regular aerobic exercise training (i.e., they engage in 30 min of structured aerobic exercise at least 3 times per week)
  • current use of hormone replacement therapy (i.e., estrogen, progesterone, and testosterone)

Treatment and study plan

Exercise Training

Behavioral

Subjects will be asked to perform exercise training (high-intensity interval training) under supervision, 3 times per week for 8 weeks. Each training session will last 40 minutes and will consist of 10-minute warm up at 70% of maximal heart rate (HRmax), four 4-minute intervals at 90% of HRmax with 3-min active recovery at 70% of HRmax and 5-minute cool down at 70% of HRmax.

Alcohol Abstinence Intervention

Behavioral

Subjects will be asked to abstain from alcohol for 8 weeks. Education materials and bi-weekly consultations will be provided.

Primary outcomes

  1. Feasibility of high-intensity interval training

    Time frame: Through out the study participation (~3 months)

    Recruitment capacity (e.g., how many subjects respond and enter to the study or reasons of refusal), resulting subject characteristics, the number of exercise session attended, and the number of dropouts

Secondary outcomes

  1. Changes in microvascular function

    Time frame: Baseline and after an 8-week intervention

    A small amount of fat will be taken form the buttock. Small vessels will then be found in the fat and their sizes in response to various flows and chemical agents will be measured.

  2. Changes in sympathetic activity

    Time frame: Baseline and after an 8-week intervention

    A small electrode will be inserted into the back of the knee to record nerve activity (bursts/min).

  3. Changes in urine catecholamine levels

    Time frame: Baseline and after an 8-week intervention

    Urine samples will be collected for 24 hours to measure norepinephrine levels (ug/g)

  4. Changes in blood pressure

    Time frame: Baseline and after an 8-week intervention

    Systolic and Diastolic blood pressure will be measured at rest and for 24 hours.

  5. Changes in alcohol intake

    Time frame: Baseline and after an 8-week intervention

    Questionnaires will be used to determine alcohol intake.

Study contacts

Contact information is provided by the study sponsor or research team.

Chueh-Lung Hwang, PhD

CONTACT

[email protected]

8172729722

Sponsors and collaborators

Lead sponsor

The University of Texas at Arlington

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Reducing Blood Pressure in Mid-life Adult Binge Drinkers: the Role of Microvascular Function and Sympathetic Activity

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Aug 30, 2022
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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