Gastroparesis

Gastroparesis Registry 2 (GpR 2): Continuation of the NIDDK Registry for the characterization and clinical course of gastroparesis patients

IRB number: HUM00063877

Study Purpose

  • To expand a registry of patients for the study of the epidemiology, etiology, and degree of morbidity associated with gastroparesis.
  • To continue to follow and expand the data collections of a well-characterized cohort to further define the natural history and clinical course of gastroparesis.
  • To provide a reliable source of recruitment of well-characterized patients with gastroparesis for therapeutic clinical trials, pathophysiological, molecular, histopathologic, or other ancillary studies.

Eligibility

  • Age Range: At least 18 years of age
  • Gender: Male & Female
  • Ethnicity: All
  • Race: All

Study Description

Patients will have scintigraphic gastric emptying test of both solids and liquids for their clinical evaluation of gastroparesis prior to study enrollment. To rule out other disorders, patients must have had an upper endoscopy within 2 years prior to registration. Information will be collected during screening using

  • medical history and physical examination;
  • validated questionnaires;
  • laboratory studies; and
  • gastric emptying test.

In addition, tests investigating the pathophysiology will include ingesting a wireless motility capsule to assess whole gut transit, autonomic function testing, electrogastrography to assess for gastric dysrhythmias, water load testing to assess for gastric accommodation. Plasma and serum samples will be saved on each patient. Patients will then be followed over time, being seen every 24 weeks, collecting information on

  • treatments being used,
  • change in medical condition; and
  • validated questionnaires assessing symptoms, abdominal pain, and quality of life.

A follow-up gastric emptying test will be obtained at the 48 week visit. Plasma and serum samples will be collected from each patient on a yearly basis.

Location of Study Visits: Ann Arbor, Michigan

Principal Investigator: William L. Hasler, MD

Questions or Referrals: Please contact Nara Wootten: 734-615-6723 or [email protected].

Nortriptyline for idiopathic gastroparesis: a multicenter, randomized, double-masked, placebo-controlled trial

IRB number: HUM00021678

Enrollment Status: CLOSED

The purpose of this study is to find out whether treatment with the medication nortriptyline is better than a placebo in improving the symptoms of gastroparesis – specifically, the type of gastroparesis called "idiopathic," which means "of unknown cause or origin." Nortriptyline is approved by the United States Food and Drug Administration for treatment of depression. It is not currently approved for treating symptoms of gastroparesis.

Eligibility

  • Age Range: From 21 to 65 years
  • Gender: Male & female
  • Ethnicity: All
  • Race: All
  • Smoking: Both smoking and non-smoking volunteers
  • Medication: Not taking medication
  • Study population: patients with symptoms of gastroparesis

Other Eligibility Factors

  • Documentation of delayed gastric emptying within 2 years.
  • Negative upper endoscopy or upper GI series within 2 years of registration date.
  • Symptoms of gastroparesis for at least 6 months (does not have to be contiguous)

Prinicipal Investigator:

  • William L Hasler, MD

Contact:

This clinical study is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). For more information provided by NIDDK, click on the following link: Nortriptyline for Idiopathic Gastroparesis