Reducing Blood Pressure in Mid-life Adult Binge Drinkers

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

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

Study Overview

• Status: Recruiting
• Conditions: Alcohol Drinking; Binge Drinking; Blood Pressure; Aging; Vasodilation; Alcohol Abstinence; Lifestyle Factors; Behavioral Problem
• Intervention / Treatment: Behavioral: Exercise Training; Behavioral: Alcohol Abstinence Intervention

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 Type: Interventional
• Enrollment (Estimated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chueh-Lung Hwang, PhD; Phone Number: 8172729722; Email: chuehlung.hwang@uta.edu

Study Locations

• United States
  • Texas
    • Arlington, Texas, United States, 76010
      • Recruiting
      • University of Texas at Arlington
      • Contact: Chueh-Lung Hwang, PhD, PT; Phone Number: 817-272-9722; Email: chuehlung.hwang@uta.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Group; 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.	Behavioral: Exercise Training; 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.; Behavioral: Alcohol Abstinence Intervention; Subjects will be asked to abstain from alcohol for 8 weeks. Education materials and bi-weekly consultations will be provided.
Active Comparator: Non-exercise Group; Binge drinkers who have been assigned to non-exercise group will receive baseline assessment, 8-week alcohol abstinence intervention, and post-intervention assessment.	Behavioral: Alcohol Abstinence Intervention; Subjects will be asked to abstain from alcohol for 8 weeks. Education materials and bi-weekly consultations will be provided.
No Intervention: Alcohol abstainer/moderate drinker group; Alcohol abstainer/moderate drinker will complete baseline assessment only and will not receive any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of high-intensity interval training	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	Through out the study participation (~3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in microvascular function	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.	Baseline and after an 8-week intervention
Changes in sympathetic activity	A small electrode will be inserted into the back of the knee to record nerve activity (bursts/min).	Baseline and after an 8-week intervention
Changes in urine catecholamine levels	Urine samples will be collected for 24 hours to measure norepinephrine levels (ug/g)	Baseline and after an 8-week intervention
Changes in blood pressure	Systolic and Diastolic blood pressure will be measured at rest and for 24 hours.	Baseline and after an 8-week intervention
Changes in alcohol intake	Questionnaires will be used to determine alcohol intake.	Baseline and after an 8-week intervention

Collaborators and Investigators

• Sponsor: The University of Texas at Arlington
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Chueh-Lung Hwang, PhD, University of Texas at Arlington

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2022
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 26, 2022
• First Posted (Actual): August 30, 2022

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Exercise training; High-intensity interval training; Microvascular function; Midlife adults; Middle-aged; Sympathetic nerve activity
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Binge Drinking; Problem Behavior; Alcohol Abstinence
• Other Study ID Numbers: 2200-0189; 4R00AA028537-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will submit to the NIMH Data Archive human subjects' data that were collected as part of the "Research Project" including microvascular function, sympathetic activity, and blood pressure. These data will be made accessible to authorized users for the purpose of scientific investigation, scholarship or teaching, or other forms of research and research development.
• IPD Sharing Time Frame: Data will be shared with authorized users upon publication (via an NDA Study) or 1-2 years after the grant end date (04/30/2025).
• IPD Sharing Access Criteria: Submit a Data Access Request to NDA and get approval

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No