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ACEM: Adrenergic Cholinergic Enteric Measures/Mapping

Sponsor
University of Louisville (Other)
Overall Status
Recruiting
CT.gov ID
NCT04013282
Collaborator
(none)
500
Enrollment
1
Location
120
Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients seen who had autonomic and enteric profiling (Adrenergic, Cholinergic, Enteric Measures/Mapping=ACEM_ from 2012-2019 at the University of Louisville.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    1. Patients seen who had autonomic and enteric profiling (Adrenergic Cholinergic Enteric Measures/Mapping=ACEM) from 2012-2019 at the U of Louisville.

    2. Results of the physiologic measures of ACEM had the results recorded.

    3. ACEM is compared to standardized gastric emptying values as the primary measure.

    4. ACEM is also compared to metabolic measures of weight, height and thus BMI as a secondary measure.

    5. ACEM is aloes compared with standardized gastrointestinal symptoms by a traditional patient recorded outcome as another secondary measure.

    Other sites may be added if they have identical IRB and/or data sharing agreements with the University of Louisville.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Adrenergic Cholinergic Enteric Measures/Mapping
    Study Start Date :
    Oct 1, 2012
    Anticipated Primary Completion Date :
    Oct 1, 2022
    Anticipated Study Completion Date :
    Oct 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Body Mass Index [10 years]

      We calculate Body Mass Index (BMI) using the following formula: weight (kg) / [height (m)] squared BMI is weight in kilograms divided by height in meters squared.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with the symptoms suggestive of autonomic and/or enteric disorders.
    Exclusion Criteria:

    • Anatomic obstruction of the GI tract

    • Pregnancy

    • Inability of patient or guardian to sign informed consent, if needed

    • Psychiatric disorders precluding assessment and treatment of the patient's GI condition.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Louisville Louisville Kentucky United States 40202

    Sponsors and Collaborators

    • University of Louisville

    Investigators

    • Principal Investigator: Thomas Abell, University of Louisville

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thomas Abell, Professor, University of Louisville
    ClinicalTrials.gov Identifier:
    NCT04013282
    Other Study ID Numbers:
    • 13.0020.02
    First Posted:
    Jul 9, 2019
    Last Update Posted:
    Jan 5, 2022
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jan 5, 2022