ObesityACEMNCT04013282
Adrenergic Cholinergic Enteric Measures/Mapping
An observational study of Obesity, run by University of Louisville at 1 site in United States.
Trial summary
Patients seen who had autonomic and enteric profiling (Adrenergic, Cholinergic, Enteric Measures/Mapping=ACEM_ from 2012-2019 at the University of Louisville. Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Obesity
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2012to 1 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients seen
Who may be able to join
- Patients with the symptoms suggestive of autonomic and/or enteric disorders.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Louisville
Louisville, Kentucky, 40202
Thomas Abell, MD
About this study
Patients seen who had autonomic and enteric profiling (Adrenergic, Cholinergic, Enteric Measures/Mapping=ACEM_ from 2012-2019 at the University of Louisville.
Read the detailed description
- Patients seen who had autonomic and enteric profiling (Adrenergic Cholinergic Enteric Measures/Mapping=ACEM) from 2012-2019 at the U of Louisville.
- Results of the physiologic measures of ACEM had the results recorded.
- ACEM is compared to standardized gastric emptying values as the primary measure.
- ACEM is also compared to metabolic measures of weight, height and thus BMI as a secondary measure.
- 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.
- Conditions
- Obesity
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start1 Oct 2012
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Abell, University of Louisville
- Investigators
- Thomas Abell, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013282
- Sponsor's protocol ID
- 13.0020.02
- Acronym
- ACEM
- Status last verified
- Jan 2025
- First submitted
- 3 Jul 2019
- Last updated
- 10 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adrenergic Cholinergic Enteric Measures/Mapping
- ClinicalTrials.gov ID
- NCT04013282
- Acronym / sponsor ID
- ACEM / 13.0020.02
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 1 Oct 2012
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients seen who had autonomic and enteric profiling (Adrenergic, Cholinergic, Enteric Measures/Mapping=ACEM_ from 2012-2019 at the University of Louisville.
Detailed description
- Patients seen who had autonomic and enteric profiling (Adrenergic Cholinergic Enteric Measures/Mapping=ACEM) from 2012-2019 at the U of Louisville.
- Results of the physiologic measures of ACEM had the results recorded.
- ACEM is compared to standardized gastric emptying values as the primary measure.
- ACEM is also compared to metabolic measures of weight, height and thus BMI as a secondary measure.
- 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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients seen
Key inclusion criteria (1 listed)
- Patients with the symptoms suggestive of autonomic and/or enteric disorders.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body Mass Index
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Abell principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas L Abell ((502)852-6991, thomas.abell@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.