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Roux en Y Gastric Bypass for Bariatric Surgery Candidates
N/A
Waitlist Available
Led By Scott Engel, PhD
Research Sponsored by Neuropsychiatric Research Institute, Fargo, North Dakota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-surgery (up to 3 months before surgery) and 1 year post surgery
Awards & highlights
Study Summary
The proposed project will help to understand the changes in reinforcement and impairment experienced by Roux en Y bariatric surgery (RYGB) patients who consume alcohol. In this study the investigators propose to investigate RYGB patients with a prospective, longitudinal design. Investigators will examine driving impairment before and after surgery as well as study cognitive changes and reinforcement changes that may occur in RYGB patients while consuming alcohol. Finally, investigators aim to better characterize the changes that occur in the pharmacokinetics of alcohol following bariatric surgery and examine key variables which may play a role in the development in alcohol use disorders.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-surgery (up to 3 months before surgery) and 1 year post surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-surgery (up to 3 months before surgery) and 1 year post surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Drive Safety RS-300 Research Driving Simulator Performance
Secondary outcome measures
Change in 2-Back task
Change in Desire-for-Drug Scale
Change in pharmacokinetics as measured via blood alcohol concentrations
Other outcome measures
Change in Addiction Severity Index (ASI)
Change in Adult Temperament Questionnaire-Short Form (ATQ-SF; Evans & Rothbart, 2007)
Change in Alcohol Use Disorders Identification Test (AUDIT; Barbor, et al., 2001)
+9 moreSide effects data
From 2017 Phase 2 trial • 17 Patients • NCT0177902459%
Increased Appetite
41%
Somnolence
35%
Euphoric mood
29%
Fatigue
12%
Memory impairment
12%
Hyperhidrosis
12%
Dizziness
12%
Nausea
6%
Feeling hot
6%
Flushing
6%
Headache
6%
Decreased appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ghrelin
Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: Roux en Y Gastric BypassExperimental Treatment1 Intervention
Participants recruited for this protocol will be those planning to undergo Roux-en-Y Gastric Bypass (RYGB). Upon study screening completion, participants will take part in a total of 4 laboratory assessment days where a fixed dose of alcohol will be given.
2 pre-surgery research appointments where participants will be given alcohol: a driving simulator day and a cognitive testing and reinforcement testing day.
2 post-surgery (1 year) research appointments where you will be given alcohol: a driving simulator day and a cognitive testing and reinforcement testing day.
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Who is running the clinical trial?
North Dakota State UniversityOTHER
21 Previous Clinical Trials
777 Total Patients Enrolled
University of KentuckyOTHER
185 Previous Clinical Trials
226,582 Total Patients Enrolled
Neuropsychiatric Research Institute, Fargo, North DakotaLead Sponsor
14 Previous Clinical Trials
794 Total Patients Enrolled
1 Trials studying Bariatric Surgery Candidates
202 Patients Enrolled for Bariatric Surgery Candidates
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