Alcohol and Bariatric Surgery (ABS)

March 7, 2025 updated by: University of Illinois at Urbana-Champaign

Pharmacokinetics and Subjective Responses to Alcohol After Bariatric Surgery

The investigators wish to study the effects of alcohol on three forms of bariatric surgery, Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG) and laparoscopic adjustable gastric banding (LAGB) and compare them with a non-surgical group. The surgery is not part of the clinical trial. If insurance does not cover the procedure, then the patient is responsible for payment of the surgical process. The investigators are doing pre and post surgery testing to provide a better understanding of the effect of bariatric surgery-induced weight loss on 1) alcohol absorption, distribution and elimination from the body, 2) the effects of alcohol on mood, and 3) the effects of alcohol on driving.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study includes seven groups of women: One group will be undergoing RYGB another group will be undergoing LAGB, a third group will be undergoing SG, the fourth group will be women who underwent RYGB 1-5 years ago, the fifth group will be women who underwent LAGB 1-5 years ago, the sixth group will be women who underwent SG 1-5 years ago and the seventh group will be women who have equivalent age and body mass index than women in the groups who underwent RYGB or SG 1-5 years ago but did not have bariatric surgery (non-surgical group).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Urbana, Illinois, United States, 61801
        • University of Illinois at Urbana Champaign

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Bariatric surgery clinic

Description

Inclusion Criteria:

  • Female
  • Drink at least 1 standard alcoholic beverage/ month
  • Underwent RYGB, SG, or LAGB 1-5 years ago or will undergo RYGB, SG, or LAGB surgery
  • Did not undergo bariatric surgery (for the non-surgical group)

Exclusion Criteria:

  • Male
  • Smoker or quit < 6 months ago
  • Anemia
  • Liver disease
  • Body weight > 450 pounds
  • Taking medications that can interact with alcohol metabolism or the subjective effects of alcohol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Gastric Bypass longitudinal
Morbidly obese subjects undergoing gastric bypass surgery. Subjects will be assessed in four testing sessions about 1 week apart in a randomized cross-over fashion before surgery. During the first two sessions, their response to alcohol or nonalcoholic (placebo) beverage will be evaluated. During testing sessions three and four, their response to alcohol administered intravenously will be evaluated. These four testing sessions will be repeated when subjects loose ~ 16% of their presurgery body weight.
Other: Oral Alcohol challenge test Alcohol visit first
Subjects will be assessed in two testing sessions about 1 week apart, in which their response to alcohol or nonalcoholic (placebo) beverage will be evaluated in a randomized cross-over fashion (visit 1 alcohol, visit 2 placebo).
Other: Oral Alcohol challenge test Placebo visit first
Subjects will be assessed in two testing sessions about 1 week apart, in which their response to alcohol or nonalcoholic (placebo) beverage will be evaluated in a randomized cross-over fashion (visit 1 placebo, visit 2 alcohol).
Other: Intravenous Alcohol Challenge Test (Clamp)
Subjects will be evaluated with an alcohol clamp (i.e. alcohol will be infused intravenously until reaching 60mg/dl and this blood alcohol concentration will be kept constant for two hours). We will record subjective responses to alcohol throughout different times of the clamp.
Other: Intravenous Alcohol Self-administration Test
Subjects will be asked to press a button ("work") to receive either a "drink" or saline through an IV catheter. The amount of alcohol infused after earning their reward will be based on their body composition and will raise their blood alcohol level by 10 mg/dl (eight time less than the legal limit for driving). We will set a safety limit to 150 mg/dl so that subjects will not be allowed to work for alcohol until their blood alcohol levels go below that limit.
Gastric Banding longitudinal
Morbidly obese subjects undergoing laparoscopic gastric banding surgery. Subjects will be assessed in four testing sessions about 1 week apart in a randomized cross-over fashion before surgery. During the first two sessions, their response to alcohol or nonalcoholic (placebo) beverage will be evaluated. During testing sessions three and four, their response to alcohol administered intravenously will be evaluated. These four testing sessions will be repeated when subjects loose ~ 16% of their presurgery body weight.
Other: Oral Alcohol challenge test Alcohol visit first
Subjects will be assessed in two testing sessions about 1 week apart, in which their response to alcohol or nonalcoholic (placebo) beverage will be evaluated in a randomized cross-over fashion (visit 1 alcohol, visit 2 placebo).
Other: Oral Alcohol challenge test Placebo visit first
Subjects will be assessed in two testing sessions about 1 week apart, in which their response to alcohol or nonalcoholic (placebo) beverage will be evaluated in a randomized cross-over fashion (visit 1 placebo, visit 2 alcohol).
Other: Intravenous Alcohol Challenge Test (Clamp)
Subjects will be evaluated with an alcohol clamp (i.e. alcohol will be infused intravenously until reaching 60mg/dl and this blood alcohol concentration will be kept constant for two hours). We will record subjective responses to alcohol throughout different times of the clamp.
Other: Intravenous Alcohol Self-administration Test
Subjects will be asked to press a button ("work") to receive either a "drink" or saline through an IV catheter. The amount of alcohol infused after earning their reward will be based on their body composition and will raise their blood alcohol level by 10 mg/dl (eight time less than the legal limit for driving). We will set a safety limit to 150 mg/dl so that subjects will not be allowed to work for alcohol until their blood alcohol levels go below that limit.
Sleeve gastrectomy longitudinal
Morbidly obese subjects undergoing sleeve gastrectomy surgery. Subjects will be assessed in four testing sessions about 1 week apart in a randomized cross-over fashion before surgery. During the first two sessions, their response to alcohol or nonalcoholic (placebo) beverage will be evaluated. During testing sessions three and four, their response to alcohol administered intravenously will be evaluated. These four testing sessions will be repeated when subjects loose ~ 16% of their presurgery body weight..
Other: Oral Alcohol challenge test Alcohol visit first
Subjects will be assessed in two testing sessions about 1 week apart, in which their response to alcohol or nonalcoholic (placebo) beverage will be evaluated in a randomized cross-over fashion (visit 1 alcohol, visit 2 placebo).
Other: Oral Alcohol challenge test Placebo visit first
Subjects will be assessed in two testing sessions about 1 week apart, in which their response to alcohol or nonalcoholic (placebo) beverage will be evaluated in a randomized cross-over fashion (visit 1 placebo, visit 2 alcohol).
Other: Intravenous Alcohol Challenge Test (Clamp)
Subjects will be evaluated with an alcohol clamp (i.e. alcohol will be infused intravenously until reaching 60mg/dl and this blood alcohol concentration will be kept constant for two hours). We will record subjective responses to alcohol throughout different times of the clamp.
Other: Intravenous Alcohol Self-administration Test
Subjects will be asked to press a button ("work") to receive either a "drink" or saline through an IV catheter. The amount of alcohol infused after earning their reward will be based on their body composition and will raise their blood alcohol level by 10 mg/dl (eight time less than the legal limit for driving). We will set a safety limit to 150 mg/dl so that subjects will not be allowed to work for alcohol until their blood alcohol levels go below that limit.
Gastric Bypass (cross-sectional)
Subjects who underwent gastric bypass surgery 1-5 years ago. Subjects will be assessed in four testing sessions about 1 week apart in a randomized cross-over fashion after surgery. During the first two sessions, their response to alcohol or nonalcoholic (placebo) beverage will be evaluated. During testing sessions three and four, their response to alcohol administered intravenously will be evaluated.
Other: Oral Alcohol challenge test Alcohol visit first
Subjects will be assessed in two testing sessions about 1 week apart, in which their response to alcohol or nonalcoholic (placebo) beverage will be evaluated in a randomized cross-over fashion (visit 1 alcohol, visit 2 placebo).
Other: Oral Alcohol challenge test Placebo visit first
Subjects will be assessed in two testing sessions about 1 week apart, in which their response to alcohol or nonalcoholic (placebo) beverage will be evaluated in a randomized cross-over fashion (visit 1 placebo, visit 2 alcohol).
Other: Intravenous Alcohol Challenge Test (Clamp)
Subjects will be evaluated with an alcohol clamp (i.e. alcohol will be infused intravenously until reaching 60mg/dl and this blood alcohol concentration will be kept constant for two hours). We will record subjective responses to alcohol throughout different times of the clamp.
Other: Intravenous Alcohol Self-administration Test
Subjects will be asked to press a button ("work") to receive either a "drink" or saline through an IV catheter. The amount of alcohol infused after earning their reward will be based on their body composition and will raise their blood alcohol level by 10 mg/dl (eight time less than the legal limit for driving). We will set a safety limit to 150 mg/dl so that subjects will not be allowed to work for alcohol until their blood alcohol levels go below that limit.
Gastric Banding (cross-sectional)
Subjects who underwent gastric banding surgery 1-5 years ago. Subjects will be assessed in four testing sessions about 1 week apart in a randomized cross-over fashion after surgery. During the first two sessions, their response to alcohol or nonalcoholic (placebo) beverage will be evaluated. During testing sessions three and four, their response to alcohol administered intravenously will be evaluated.
Other: Oral Alcohol challenge test Alcohol visit first
Subjects will be assessed in two testing sessions about 1 week apart, in which their response to alcohol or nonalcoholic (placebo) beverage will be evaluated in a randomized cross-over fashion (visit 1 alcohol, visit 2 placebo).
Other: Oral Alcohol challenge test Placebo visit first
Subjects will be assessed in two testing sessions about 1 week apart, in which their response to alcohol or nonalcoholic (placebo) beverage will be evaluated in a randomized cross-over fashion (visit 1 placebo, visit 2 alcohol).
Other: Intravenous Alcohol Challenge Test (Clamp)
Subjects will be evaluated with an alcohol clamp (i.e. alcohol will be infused intravenously until reaching 60mg/dl and this blood alcohol concentration will be kept constant for two hours). We will record subjective responses to alcohol throughout different times of the clamp.
Other: Intravenous Alcohol Self-administration Test
Subjects will be asked to press a button ("work") to receive either a "drink" or saline through an IV catheter. The amount of alcohol infused after earning their reward will be based on their body composition and will raise their blood alcohol level by 10 mg/dl (eight time less than the legal limit for driving). We will set a safety limit to 150 mg/dl so that subjects will not be allowed to work for alcohol until their blood alcohol levels go below that limit.
Sleeve gastrectomy (cross-sectional)
Subjects who underwent sleeve gastrectomy surgery 1-5 years ago. Subjects will be assessed in four testing sessions about 1 week apart in a randomized cross-over fashion after surgery. During the first two sessions, their response to alcohol or nonalcoholic (placebo) beverage will be evaluated. During testing sessions three and four, their response to alcohol administered intravenously will be evaluated.
Other: Oral Alcohol challenge test Alcohol visit first
Subjects will be assessed in two testing sessions about 1 week apart, in which their response to alcohol or nonalcoholic (placebo) beverage will be evaluated in a randomized cross-over fashion (visit 1 alcohol, visit 2 placebo).
Other: Oral Alcohol challenge test Placebo visit first
Subjects will be assessed in two testing sessions about 1 week apart, in which their response to alcohol or nonalcoholic (placebo) beverage will be evaluated in a randomized cross-over fashion (visit 1 placebo, visit 2 alcohol).
Other: Intravenous Alcohol Challenge Test (Clamp)
Subjects will be evaluated with an alcohol clamp (i.e. alcohol will be infused intravenously until reaching 60mg/dl and this blood alcohol concentration will be kept constant for two hours). We will record subjective responses to alcohol throughout different times of the clamp.
Other: Intravenous Alcohol Self-administration Test
Subjects will be asked to press a button ("work") to receive either a "drink" or saline through an IV catheter. The amount of alcohol infused after earning their reward will be based on their body composition and will raise their blood alcohol level by 10 mg/dl (eight time less than the legal limit for driving). We will set a safety limit to 150 mg/dl so that subjects will not be allowed to work for alcohol until their blood alcohol levels go below that limit.
Non-surgical group
Subjects who are age and body mass index equivalent to gastric bypass (cross-sectional) and Sleeve gastrectomy (cross-sectional) but did not undergo any type of bariatric surgery. Subjects will be assessed in four testing sessions about 1 week apart in a randomized cross-over fashion after surgery. During the first two sessions, their response to alcohol or nonalcoholic (placebo) beverage will be evaluated. During testing sessions three and four, their response to alcohol administered intravenously will be evaluated.
Other: Oral Alcohol challenge test Alcohol visit first
Subjects will be assessed in two testing sessions about 1 week apart, in which their response to alcohol or nonalcoholic (placebo) beverage will be evaluated in a randomized cross-over fashion (visit 1 alcohol, visit 2 placebo).
Other: Oral Alcohol challenge test Placebo visit first
Subjects will be assessed in two testing sessions about 1 week apart, in which their response to alcohol or nonalcoholic (placebo) beverage will be evaluated in a randomized cross-over fashion (visit 1 placebo, visit 2 alcohol).
Other: Intravenous Alcohol Challenge Test (Clamp)
Subjects will be evaluated with an alcohol clamp (i.e. alcohol will be infused intravenously until reaching 60mg/dl and this blood alcohol concentration will be kept constant for two hours). We will record subjective responses to alcohol throughout different times of the clamp.
Other: Intravenous Alcohol Self-administration Test
Subjects will be asked to press a button ("work") to receive either a "drink" or saline through an IV catheter. The amount of alcohol infused after earning their reward will be based on their body composition and will raise their blood alcohol level by 10 mg/dl (eight time less than the legal limit for driving). We will set a safety limit to 150 mg/dl so that subjects will not be allowed to work for alcohol until their blood alcohol levels go below that limit.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in the peak blood alcohol level achieved before-after bariatric surgery and among bariatric surgery and control groups
Time Frame: Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.
Time to reach peak blood alcohol levels and height of blood alcohol levels will be examined before and after surgery and compared between those who had gastric bypass or gastric sleeve versus lap banding and the non-surgery control group.
Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.
Change in alcohol subjective effects from pre- to post- bariatric surgery and among bariatric surgery and control groups
Time Frame: Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.
Validated instruments (such as the Addiction Research Center Inventory and the biphasic alcohol effect scale) will be used to measure alcohol's subjective effects at different timepoints after drinking an alcoholic or a non-alcoholic (control) beverage as well as receiving alcohol vs placebo orally or alcohol intravenously
Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.
Change in the area under the curve for blood alcohol concentration (BAC) versus time pre- to post-bariatric surgery and among different bariatric surgery groups and controls
Time Frame: Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.
The area under the curve for BAC will be examined before and after surgery and compared among those who had gastric bypass or gastric sleeve versus lap banding or the non-surgery control group.
Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.
Change in the rate of alcohol elimination between pre- and post-surgery and among the different bariatric surgery groups and the control groups.
Time Frame: Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.
The systemic alcohol elimination rate calculated from the alcohol infusion rate during the iv alcohol clamp technique will be compared pre- to post- surgery and among bariatric and control groups
Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in alcohol's effects on glucose homeostasis [pre- to post-surgery and among bariatric surgery groups and control groups.
Time Frame: Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.
mmol/L
Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.
Changes in alcohol's effects on insulin [pre- to post-surgery and among bariatric surgery groups and control groups.
Time Frame: Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.
pmol/L
Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.
Changes in alcohol's effects on C-peptide [pre- to post-surgery and among bariatric surgery groups and control groups.
Time Frame: Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.
nmol/L
Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.
Changes in alcohol's effects on FGF21 [pre- to post-surgery and among bariatric surgery groups and control groups.
Time Frame: Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.
pg/ml
Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.
Changes in alcohol's effects on ghrelin [pre- to post-surgery and among bariatric surgery groups and control groups.
Time Frame: Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.
pg/ml
Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.
Changes in alcohol's effects on GLP-1 [pre- to post-surgery and among bariatric surgery groups and control groups.
Time Frame: Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.
pmol/L
Subjects in the longitudinal arm of the study will be assessed before surgery and approximately 9 months after surgery. A group of subjects will be assessed 1-5 years after surgery only.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Urbana-Champaign

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Carle Foundation Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marta Y Pepino de Gruev, PhD, UIUC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 25, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16135
  • 17205 (UIUC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

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