Adrenergic Cholinergic Enteric Measures/Mapping

Obesity Clinical Trial

— ACEM  

Official title:

Adrenergic Cholinergic Enteric Measures/Mapping

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04013282
• Other study ID #: 13.0020.02
• Status: Recruiting
• Start date: October 1, 2012
• Est. completion date: October 1, 2024

Study information

• Verified date: April 2024
• Source: University of Louisville
• Contact: Thomas L Abell
• Phone: (502)852-6991
• Email: thomas.abell[@]louisville.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 years