Aging Clinical Trial
Official title:
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
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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas at Arlington | Arlington | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas at Arlington | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
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 |
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