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Recruiting NCT04013282

Adrenergic Cholinergic Enteric Measures/Mapping

Observational Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Obesity. Basic parameters: 10 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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.

Primary outcome measures

  • Body Mass Index [Time frame: 10 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • University of Louisville — Louisville

Identifiers

NCT: NCT04013282 · 13.0020.02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗