Reducing Blood Pressure in Mid-life Adult Binge Drinkers

The University of Texas System (UT)

Status: Enrolling

Conditions: Aging; Vasodilation; Behavioral Problem; Alcohol Abstinence; Lifestyle Factors; Blood Pressure; Binge Drinking; Alcohol Drinking

Treatments: Behavioral: Alcohol Abstinence Intervention; Behavioral: Exercise Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05522075

2200-0189

4R00AA028537-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 55 estimated patients

Sex: All

Ages: 50 to 64 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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55 participants in 3 patient groups

Exercise Group

Experimental group

Description:

Binge drinkers who have been assigned to exercise group will receive baseline assessment, 8-week exercise training plus alcohol abstinence intervention, and post-intervention assessment.

Treatment:

Behavioral: Exercise Training

Behavioral: Alcohol Abstinence Intervention

Non-exercise Group

Active Comparator group

Description:

Binge drinkers who have been assigned to non-exercise group will receive baseline assessment, 8-week alcohol abstinence intervention, and post-intervention assessment.

Treatment:

Behavioral: Alcohol Abstinence Intervention

Alcohol abstainer/moderate drinker group

No Intervention group

Description:

Alcohol abstainer/moderate drinker will complete baseline assessment only and will not receive any intervention.