Gastric Motor Function Measurement in Dyspepsia and Normal Subjects

NCT00296582 | Completed

• 1 other identifier: 65-06
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dyspepsia

Outcome Measures

Primary Outcomes (1)

• Fasting and postprandial gastric volumes (Gastric accommodation)

Secondary Outcomes (3)

• T1/2 of gastric emptying of solid

• Maximum tolerated volume

• Individual postprandial symptom scores

Interventions

Gastric Motor Function Measurement BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• H. Jae Kim, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 24, 2006
• First Posted: February 27, 2006
• Study Start: January 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: May 23, 2011

Record last verified: 2011-05

Locations

US (1)