Gastric Motor Function Measurement in Dyspepsia and Normal Subjects

Simultaneous Gastric Motor Function Measurement in Dyspepsia And Normal Subjects Ingesting a Solid-Liquid Meal

This study is being done to measure the functions of the stomach after eating a meal and to develop a new method that will simultaneously measure both gastric emptying and the relaxation of the stomach after a meal using nuclear medicine testing. This would make the testing more convenient for patients and will also offer better understanding of these two gastric functions.

Study Overview

• Status: Completed
• Conditions: Dyspepsia
• Intervention / Treatment: Behavioral: Gastric Motor Function Measurement

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

Dyspeptic Subjects:

• Recurrent episodes of upper abdominal pain or discomfort including early satiety, fullness, bloating, or nausea for at least 3 months in the prior year.
• A baseline impaired satiety test (maximum tolerated volume 25% of normal or 1000cc).
• No evidence on esophagogastroduodenoscopy of erosions, peptic ulcer, pyloric obstruction, esophagitis or malignancy in the prior 3 years.

All Subjects:

• No history suggestive of small bowel obstruction.

Exclusion criteria

• No structural or metabolic diseases/conditions that affect the gastrointestinal system.

• Unable to stop medications 48 hours prior to the study that:

  • Alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, SSRI and newer antidepressants.
  • Analgesic drugs including opiates, NSAID, COX 2 inhibitors
  • Systemic antifungal drugs
  • Carbamazepine, glucocorticoids, phenobarbital, phenytoin, rifampin, but also grapefruit juice.
  • Benzodiazepines NOTE: Low stable doses of thyroid replacement, estrogen replacement, low dose aspirin for cardioprotection and birth control pills or depot injections are permissible.
• Female subjects who are pregnant or breast feeding.
• Significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study.
• Subjects who have participated in another clinical study within the past 30 days.
• Previous gastric or intestinal surgery (except appendectomy , cholecystectomy or hysterectomy).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Fasting and postprandial gastric volumes (Gastric accommodation)

Secondary Outcome Measures

Outcome Measure
T1/2 of gastric emptying of solid
Maximum tolerated volume
Individual postprandial symptom scores

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: H. Jae Kim, M.D., Mayo Clinic

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: February 24, 2006
• First Submitted That Met QC Criteria: February 24, 2006
• First Posted (Estimate): February 27, 2006

Study Record Updates

• Last Update Posted (Estimate): May 23, 2011
• Last Update Submitted That Met QC Criteria: May 20, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: 65-06