Clinical trial NCT05522075: Reducing Blood Pressure in Mid-life Adult Binge Drinkers
Official title: Reducing Blood Pressure in Mid-life Adult Binge Drinkers: the Role of Microvascular Function and Sympathetic Activity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Drinking
Binge Drinking
Blood Pressure
Alcohol Abstinence
Aging
Lifestyle Factors
Vasodilation
Behavioral Problem
Keywords: Exercise training
High-intensity interval training
Midlife adults
Middle-aged
Microvascular function
Sympathetic nerve activity
Lead sponsor: The University of Texas at Arlington
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-08-30
Enrollment: 55
Sex: ALL
Minimum age (years): 50
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Feasibility of high-intensity interval training
timeFrame: Through out the study participation (~3 months)
Secondary outcomes:
measure: Changes in microvascular function
timeFrame: Baseline and after an 8-week intervention
measure: Changes in sympathetic activity
timeFrame: Baseline and after an 8-week intervention
measure: Changes in urine catecholamine levels
timeFrame: Baseline and after an 8-week intervention
measure: Changes in blood pressure
timeFrame: Baseline and after an 8-week intervention
measure: Changes in alcohol intake
timeFrame: Baseline and after an 8-week intervention
Other outcomes:
Locations:
city: Arlington
country: United States
facility: University of Texas at Arlington
state: Texas
Study officials:
affiliation: University of Texas at Arlington
name: Chueh-Lung Hwang, PhD
role: PRINCIPAL_INVESTIGATOR
References: