Reducing Blood Pressure in Mid-life Adult Binge Drinkers

Not Applicable

Recruiting

• Conditions: Lifestyle Factors; Binge Drinking; Behavioral Problem; Alcohol Drinking; Vasodilation; Blood Pressure; Aging; Alcohol Abstinence
• Interventions: Behavioral: Exercise Training; Behavioral: Alcohol Abstinence Intervention

• Registration Number: NCT05522075
• Lead Sponsor: The University of Texas at Arlington

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.

Study Timeline

• Study First Submitted: 2022-08-22
• Study First Submitted QC: 2022-08-26
• Study First Posted: 2022-08-30
• Study Start: 2022-11-21
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-10-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 55

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Group	Exercise Training	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.
Exercise Group	Alcohol Abstinence Intervention	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.
Non-exercise Group	Alcohol Abstinence Intervention	Binge drinkers who have been assigned to non-exercise group will receive baseline assessment, 8-week alcohol abstinence intervention, and post-intervention assessment.

Primary Outcome Measures

Name	Time	Method
Feasibility of high-intensity interval training	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 Outcome Measures

Name	Time	Method
Changes in blood pressure	Baseline and after an 8-week intervention	Systolic and Diastolic blood pressure will be measured at rest and for 24 hours.
Changes in urine catecholamine levels	Baseline and after an 8-week intervention	Urine samples will be collected for 24 hours to measure norepinephrine levels (ug/g)
Changes in alcohol intake	Baseline and after an 8-week intervention	Questionnaires will be used to determine alcohol intake.
Changes in microvascular function	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.
Changes in sympathetic activity	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).

Trial Locations

Locations (1)

University of Texas at Arlington; 🇺🇸 Arlington, Texas, United States