Study to Evaluate Gastric Emptying and Accommodation in Bariatric Surgery Patients by Establishing and Validating a New Protocol and Normative Values

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 18-008847
    Sponsor Protocol Number: 18-008847

About this study

The purpose of this study is to establish a new protocol and normative values for evaluating gastric emptying and accommodation in bariatric surgery patients.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Able to provide written informed consent prior to any study procedures.
  • Willing and able to comply with study procedures.
  • No medical problems or chronic diseases for healthy volunteers.
  • No prior diagnosis of gastroparesis in bariatric surgery groups.
  • Body mass index of 18-27 kg/m2 for healthy volunteers.
  • Body mass index of 18-40 kg/m2 for bariatric surgery groups; type 2 diabetes is permissible as long as there are no exclusion criteria.
  • Female subjects must have negative urine pregnancy tests and must not be lactating prior to radiation exposure.
  • Ability and willingness to eat all components of the test meal.

Exclusion Criteria:

  • Unable or unwilling to provide informed consent.
  • Unable or unwilling to comply with study procedures.
  • Prior alteration of gastric anatomy.
  • Known or suspected gastroparesis.
  • Use of drugs known to alter gastrointestinal function including opiates, GLP1 agonists and analogs and medications known to affect gastric emptying.
  • History of recent surgery (within 60 days of screening) in the healthy volunteer group.
  • Acute or chronic illness or history of illness which in the opinion of the investigator could pose a threat or harm to the subject or obscure interpretation of laboratory test results or interpretation of study data, such as frequent angina, Class III or IV congestive heart failure, moderate impairment of renal or hepatic function, poorly controlled diabetes (HbA1c >12%), etc.
  • Any clinically significant abnormalities on physical examination or laboratory abnormalities identified in the medical record, as determined by the investigator.
  • Acute GI illness within 48 hours of initiation of the baseline period.
  • Females who are pregnant or breastfeeding.
  • History of excessive alcohol use or substance abuse.
  • Any other reason, which in the opinion of the investigator, would confound proper interpretation of the study.
  • Body weight more than 500 lbs.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Michael Camilleri, M.D.

Open for enrollment

Contact information:

Kayla Arndt

(507)538-6599

Arndt.Kayla@mayo.edu

More information

Study Progress

This study has completed enrollment of targeted participants and currently is completing research activities including study intervention, specimen collection, testing and data analysis.

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20445693

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