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OpenTrials
Completed

NCT Number: NCT03178370

Autonomic and Enteric Profiling

Autonomic, inflammatory, enteric, electrophysiologic and hormonal.

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Key information

Conditions

Gastroparesis Abdominal Pain Digestive System Diseases Gastrointestinal Diseases Inflammation Nausea Neurologic Manifestations Pain Paralysis Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Stomach Diseases Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Patients were evaluated by two methods in each of five areas: inflammatory, autonomic, enteric, electrophysiologic, and hormonal.

In part one, patients had similar GI Symptoms regardless of baseline gastric emptying or diabetic/non-diabetic status and all patients demonstrated abnormalities in each of the 5 areas studied.

In part two, patients showed early and late effects of electrical stimulation with changes noted in multiple areas, categorized by improvement status.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willingness to participate in study and sign informed consent.
  • Age 18 or older.
  • Symptoms of gastroparesis for at least 6 months.
  • Refractory or intolerant to antiemetic drugs.
  • Refractory or intolerant to prokinetic drugs.
  • If Diabetic, documentation of medication for diabetes for at least 6 months.
  • No evidence of anatomic obstruction of GI tract. -

Exclusion criteria

  • Previous gastric surgery.
  • History or evidence of rumination syndrome, eating disorder of primary psychiatric disorder.
  • No know collagen vascular disease.
  • Inability or unwillingness to participate in the study.
  • Current active gastric stimulation or other gastrointestinal neurostimulation implant or device.
  • Pregnancy.

Treatment and study plan

Gastric Electrical Stimulation

Device

Temporary and permanent gastric electrical stimulation

Primary outcomes

  1. Gastrointestinal symptoms

    Time frame: Change from baseline to 6 days to 6 months

    By standardized symptom scoring

Secondary outcomes

  1. Gastric Emptying Test

    Time frame: baseline, 6 days, 6 months

    By gastric emptying test

  2. Autonomic

    Time frame: Change from baseline to 6 days to 6 months

    By autonomic function

  3. Hormones

    Time frame: Change from baseline to 6 days to 6 months

    By serum measures

  4. Inflammation

    Time frame: Change from baseline to 6 days to 6 months

    By serum measures

  5. Gastric emptying

    Time frame: baseline, 6 days, 6 months

    By radionuclides

  6. Electrophysiology

    Time frame: Change from baseline to 6 days to 6 months

    By Electrogastrogram(EGG)/ Electrogram (EG)

  7. Quality of life by IDIOMS

    Time frame: Change from baseline to 6 days to 6 months

    By standardized scale

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Autonomic and Enteric Profiling in Relation to Body Weight

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 6, 2017
Registry last updated
Oct 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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