Reducing Blood Pressure in Mid-life Adult Binge Drinkers

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05522075
• Other study ID #: 2200-0189
• Secondary ID: 4R00AA028537-03
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: January 2024
• Source: The University of Texas at Arlington
• Contact: Chueh-Lung Hwang, PhD
• Phone: 8172729722
• Email: chuehlung.hwang[@]uta.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: April 30, 2025
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 64 Years

Eligibility

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)

Related Conditions & MeSH terms

• Aging
• Alcohol Abstinence
• Alcohol Drinking
• Behavioral Problem
• Binge Drinking
• Blood Pressure
• Lifestyle Factors
• Problem Behavior
• Vasodilation

Intervention

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

Locations

Country	Name	City	State
United States	University of Texas at Arlington	Arlington	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas at Arlington	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in alcohol intake	Questionnaires will be used to determine alcohol intake.	Baseline and after an 8-week intervention