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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AA024892-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Chicago | OTHER |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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This study evaluates the impact of evening alcohol consumption on sympathetic activity and baroreflex function in binge drinkers. Our central hypothesis is that evening binge alcohol consumption will lead to sympathetic overactivity and blunted baroreflex function.
This study will recruit male and female binge drinkers who will participate in a randomized, cross-over, double-blind, placebo-based study to examine the impact of an evening of alcohol vs. placebo/fluid-control on autonomic and cardiovascular control at night and the subsequent morning. The study will utilize established techniques for assessing sleep (polysomnography) and autonomic/cardiovascular control (microneurography, beat-to-beat finger plethysmography, electrocardiogram, etc.). All subjects will undergo a familiarization night in the sleep laboratory prior to their first randomized test session with either alcohol or placebo/fluid-control. Both men and women will be tested to address a secondary aim of determining the impact of sex (male vs. female) and ovarian cycle (early follicular vs. midluteal phase) on sympathetic neural responsiveness to evening alcohol in binge drinkers. Finally, as a tertiary/exploratory aim, participants that have a respiratory disturbance index of ≥5 episodes per hour during the alcohol treatment will be asked to consider one additional overnight session where they will be randomly assigned to either continuous positive airway pressure (CPAP) or sham-CPAP for one additional night of evening alcohol consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluid Control | Placebo Comparator | Participants first received a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. After at least a one-month washout period, they then received the alcohol condition. |
|
| Alcohol | Experimental | Participants first received the alcohol condition with 95% ethanol and fruit juice (1:3 ratio). After at least a one-month washout period, they then received the fluid control condition with a volume fluid match. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcohol vs. Placebo | Other | Using a randomized, cross-over design, all subjects will consume evening alcohol (and a fluid-control placebo) in a dose that mimics binge drinking. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sympathetic Nerve Activity Burst Frequency | Direct recordings of muscle sympathetic nerve activity (MSNA) from the peroneal nerve using a microelectrode. | 1 month |
| Sympathetic Nerve Activity Burst Incidence | Direct recordings of muscle sympathetic nerve activity (MSNA) from the peroneal nerve using a microelectrode. Burst incidence is calculated as the number of sympathetic bursts per 100 heartbeats. This measure takes into account varying heart rates on sympathetic activity by normalizing to each individual's heartbeat. Higher calculated number equates to higher sympathetic activity. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous Sympathetic Baroreflex Sensitivity | The linear relationship between beat-to-beat blood pressure and sympathetic nerve activity expressed as bursts/100 heart beats. Sympathetic baroreflex sensitivity is determined using the slope of the weighted linear regression of diastolic blood pressure and MSNA burst incidence. Diastolic blood pressure values of individual cardiac cycles were binned into 3 mmHg intervals, and the MSNA burst incidence was determined and subsequently plotted against corresponding diastolic blood pressure bins. |
| Measure | Description | Time Frame |
|---|---|---|
| Nocturnal Blood Pressure Dip | Change in nocturnal blood pressure during sleep when compared to evening/morning wakefulness. | 1 month |
| Sleep Quality | Polysomnography will be used to determine the quality of sleep, with a primary focus on the apnea-hypopnea index. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Carter | Baylor University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montana State University | Bozeman | Montana | 59717 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39119705 | Derived | Bigalke JA, Greenlund IM, Solis-Montenegro TX, Durocher JJ, Joyner MJ, Carter JR. Binge Alcohol Consumption Elevates Sympathetic Transduction to Blood Pressure: A Randomized Controlled Trial. Hypertension. 2024 Oct;81(10):2140-2151. doi: 10.1161/HYPERTENSIONAHA.124.23416. Epub 2024 Aug 9. | |
| 34015116 | Derived | Greenlund IM, Bigalke JA, Tikkanen AL, Durocher JJ, Smoot CA, Carter JR. Evening binge alcohol disrupts cardiovagal tone and baroreflex function during polysomnographic sleep. Sleep. 2021 Nov 12;44(11):zsab130. doi: 10.1093/sleep/zsab130. |
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The scientific field of neural cardiovascular control in humans does not, at present, have a common data repository that would be applicable to this project. However, all data will be stored on secure University server in a de-identified manner, and investigators will make raw data available to individuals, groups, and organizations upon request and when appropriate.
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38/169 participants were randomized. Of the 131 that were not randomized 100 did not meet inclusion criteria or did not consent and 31 were lost to follow-up/drop out.
Participants were recruited by word-of-mouth and advertisements. 169 participants were screened for eligibility.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluid Control, Then Alcohol | Participants first received a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. After at least a one-month washout period, they then received the alcohol condition. Alcohol vs. Placebo: Using a randomized, cross-over design, all subjects will consume evening alcohol (and a fluid-control placebo) in a dose that mimics binge drinking. |
| FG001 | Alcohol, Then Fluid Control | Participants first received the alcohol condition with 95% ethanol and fruit juice (1:3 ratio). After at least a one-month washout period, they then received the fluid control condition with a volume fluid match. Alcohol vs. Placebo: Using a randomized, cross-over design, all subjects will consume evening alcohol (and a fluid-control placebo) in a dose that mimics binge drinking. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluid Control, Then Alcohol | Participants first received a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. After at least a one-month washout period, they then received the alcohol condition. Alcohol vs. Placebo: Using a randomized, cross-over design, all subjects will consume evening alcohol (and a fluid-control placebo) in a dose that mimics binge drinking. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sympathetic Nerve Activity Burst Frequency | Direct recordings of muscle sympathetic nerve activity (MSNA) from the peroneal nerve using a microelectrode. | 26 total participants were analyzed for primary outcome measures that completed both arms (fluid control vs. alcohol) of the study, using a randomized crossover design. | Posted | Mean | Standard Deviation | Burst/Min | 1 month |
|
On average 1 to 2 months following initial laboratory testing session
Participants were monitored for minor and serious adverse events throughout the protocol. Participants were not at risk for all-cause mortality and were not monitored for all-cause mortality. All participants were young healthy (male/female) adults and were screened for serious disorders that may predispose them towards unanticipated adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fluid Control | All participants received both a binge alcohol dose (0.85g/kg for females, 1.0g/kg for males) and a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. These conditions were provided in a randomized, crossover design, and were separated by 1-month washout. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jason Carter | Baylor University | 254-710-4499 | jason_carter1@baylor.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 21, 2022 | Jun 26, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D063425 | Binge Drinking |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D000428 | Alcohol Drinking |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| 1 month |
| 1 month |
| Sympathetic Reactivity | The change in muscle sympathetic nerve activity during an acute laboratory stressor. | 1 month |
| BG001 | Alcohol, Then Fluid Control | Participants first received the alcohol condition with 95% ethanol and fruit juice (1:3 ratio). After at least a one-month washout period, they then received the fluid control condition with a volume fluid match. Alcohol vs. Placebo: Using a randomized, cross-over design, all subjects will consume evening alcohol (and a fluid-control placebo) in a dose that mimics binge drinking. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
All participants received both a binge alcohol dose (0.85g/kg for females, 1.0g/kg for males) and a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. These conditions were provided in a randomized, crossover design, and were separated by 1-month washout. |
|
|
|
| Primary | Sympathetic Nerve Activity Burst Incidence | Direct recordings of muscle sympathetic nerve activity (MSNA) from the peroneal nerve using a microelectrode. Burst incidence is calculated as the number of sympathetic bursts per 100 heartbeats. This measure takes into account varying heart rates on sympathetic activity by normalizing to each individual's heartbeat. Higher calculated number equates to higher sympathetic activity. | 26 total participants were analyzed for primary outcome measures that completed both arms (fluid control vs. alcohol) of the study, using a randomized crossover design. | Posted | Mean | Standard Deviation | burst/100 heart beats | 1 month |
|
|
|
| Secondary | Spontaneous Sympathetic Baroreflex Sensitivity | The linear relationship between beat-to-beat blood pressure and sympathetic nerve activity expressed as bursts/100 heart beats. Sympathetic baroreflex sensitivity is determined using the slope of the weighted linear regression of diastolic blood pressure and MSNA burst incidence. Diastolic blood pressure values of individual cardiac cycles were binned into 3 mmHg intervals, and the MSNA burst incidence was determined and subsequently plotted against corresponding diastolic blood pressure bins. | 11 total participants were analyzed for the secondary outcome measure that completed both arms of the study (fluid control vs. alcohol), with a randomized crossover design. | Posted | Mean | Standard Deviation | MSNA Bursts/100 heart beats/mmHg | 1 month |
|
|
|
|
| Other Pre-specified | Nocturnal Blood Pressure Dip | Change in nocturnal blood pressure during sleep when compared to evening/morning wakefulness. | Not Posted | 1 month | Participants |
| Other Pre-specified | Sleep Quality | Polysomnography will be used to determine the quality of sleep, with a primary focus on the apnea-hypopnea index. | Not Posted | 1 month | Participants |
| Other Pre-specified | Sympathetic Reactivity | The change in muscle sympathetic nerve activity during an acute laboratory stressor. | Not Posted | 1 month | Participants |
| 0 |
| 0 |
| 0 |
| 38 |
| 2 |
| 38 |
| EG001 | Alcohol | All participants received both a binge alcohol dose (0.85g/kg for females, 1.0g/kg for males) and a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. These conditions were provided in a randomized, crossover design, and were separated by 1-month washout. | 0 | 0 | 0 | 38 | 1 | 38 |
| Presyncope in response to venipuncture | Nervous system disorders | Systematic Assessment |
|
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| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D001523 | Mental Disorders |