Gastric vs Jejunal Feeding in Diabetic Gastroparesis

This study has been withdrawn prior to enrollment.
(Principle Investigator moved to another institution. Research funds transferred. Study to be performed at new institution)
Sponsor:
Collaborator:
Schweizerischer Nationalfonds
Information provided by (Responsible Party):
MFox, University of Zurich
ClinicalTrials.gov Identifier:
NCT00944593
First received: July 20, 2009
Last updated: April 2, 2012
Last verified: April 2012
  Purpose

Diabetic 'Gastroparesis' or 'Gastroenteropathy' is a condition in which patients suffer episodes of nausea, vomiting, abdominal bloating and pain after eating. These symptoms occur in the absence of any structural abnormality of the stomach, rather abnormal gastric function underlies the condition. Up to one in five patients with type I diabetes experience symptoms consistent with this diagnosis. The effects on diabetic control, physical health and emotional quality of life are severe. Patients do not respond reliably to general supportive management or conventional medications. Surgical options have disappointing results. The need for more effective treatment is acknowledged universally.

Feeding into the small bowel beyond the stomach (jejunal feeding) is established management in diabetic patients with gastroenteropathy that are malnourished due to poor oral intake. The benefits have been assumed secondary to improved nutrition and diabetic control; however this assertion has never been studied. Recently we observed that patients with severe gastroenteropathy recovered promptly and could eat normally during and for a few hours after jejunal feeding. These observations suggest that jejunal feeding has 'quasi-pharmacological' effects in patients with gastroenteropathy. One attractive explanation for these observations is that gastroenteropathy represents a failure of oral intake to 'switch' the stomach from the fasted to the fed state. According to this hypothesis, jejunal feeding 'restores' the normal fed state by bypassing the dysfunctional stomach.

This project will assess the effects of feeding on gastrointestinal (GI) sensory and motor function in diabetic gastroenteropathy. Healthy volunteers and diabetic controls without symptoms will also be investigated. Studies will assess:

  1. Effects on GI symptoms and function to gastric distension in fasted and fed states
  2. Effects on GI symptoms and function to oral vs. nasogastric delivery of a test meal
  3. A trial of gastric feeding with and without prior jejunal feeding on GI symptoms and function Non-invasive magnetic resonance imaging (MRI) techniques will be applied to assess complex gastric response to feeding. In addition the effects of feeding on symptoms and gastric function will be related to alterations in GI hormones and autonomic nervous activity (eg cardiovagal tone) to assess how the integrated response of the GI tract to feeding fails in patients with diabetic gastroenteropathy.

The primary aim of this project is to assess the effectiveness of jejunal feeding in the management of diabetic gastroenteropathy. However, by defining the processes that 'switch' gastric function between the fasted and the fed states and control gastric emptying, we hope also to identify candidate targets for more effective pharmacologic treatment of this severe disease.

  • Trial with medical device

Condition Intervention Phase
Diabetic Gastroparesis
Dietary Supplement: Jejunal Feed
Dietary Supplement: Normal Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Gastric Meal With and Without Prior Jejunal Feeding on GI Symptoms and Response in Patients With Diabetic Gastro-enteropathy, Diabetic Controls and Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Improvement in symptoms of gastroparesis (GCSI score) [ Time Frame: After administration of test meal ] [ Designated as safety issue: No ]
    Comparison will be made of symptoms of gastroparesis (GCSI score) after test meal with and without prior jejunal feeding. Symptoms will be assessed after administration and at regular 15 min intervals for 120 min. An integrated score will be calculated.


Secondary Outcome Measures:
  • Gastric emptying rate at gastric emptying half time [ Time Frame: 120 min ] [ Designated as safety issue: No ]
    A 400ml liquid test meal will be taken. Dynamic change in gastric volume over time will be assessed using a validated 4 parameter model. Gastric emptying rate will be assessed at the time half the gastric volume has left the stomach ("gastric emptying half time")


Enrollment: 0
Estimated Study Completion Date: January 2011
Arms Assigned Interventions
Experimental: 300kcal liquid Nutrient
300kcal liquid nutrient delivered by NJ tube over 60 minutes before ingestion of a standard oral liquid nutrient test meal
Dietary Supplement: Jejunal Feed
Liquid nutrient (Ensure 200ml (300kcal) over 60 minutes) will be delivered by naso-jejunal feeding tube (previously placed by endoscopy)
Other Name: Ensure Vanilla, Abbott
Placebo Comparator: Normal Saline
Normal Saline delivered via NJ tube over 60 minutes ahead of a standard liquid nutrient test meal
Dietary Supplement: Normal Saline
200ml Normal Saline 0.9%
Other Name: Normal Saline 0.9%, Baxter

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria: • Type 1 diabetes mellitus, confirmed by history of persistent insulin treatment from 12 months' or less after diagnosis, and fasting C peptide concentration of <0.16nmol/L.74

  • At least moderate symptoms of gastroenteropathy (GCSI >27)
  • Delayed gastric emptying on breath test performed at screening (if no results available)

Disease control

  • Type 1 diabetes mellitus, confirmed by history of persistent insulin treatment from 12 months' or less after diagnosis, and fasting C peptide concentration of <0.16nmol/L.74
  • Not more than mild symptoms of gastroenteropathy / dyspepsia (GCSI <14).
  • Normal gastric emptying on breath test performed at screening (if no results available)

Normal control

  • Healthy volunteers recruited by advertisement.
  • Not more than mild symptoms of gastroenteropathy / dyspepsia (GCSI <14).
  • Normal gastric emptying on breath test performed at screening (if no results available)

General inclusion criteria

  • Aged at least 18 and not more than 55 years.
  • Body Mass Index: 19-27 kg/m2
  • Ability to communicate with the investigator and comply with requirements for entire study.
  • Ability to provide written, informed consent

Exclusion criteria: General exclusion criteria

  • Gross retention of gastric contents (e.g. bezoar) or evidence of peptic ulcer disease or significant pathology (other than reflux oesophagitis) on upper gastrointestinal endoscopy
  • History of gastro-intestinal surgery (except appendicectomy and hernia repair).
  • History of abdominal radiotherapy or malignancy
  • Mental impairment or psychological disease limiting ability to comply with study requirements
  • Progressive or unstable co-morbid condition requiring treatment or precluding safe endoscopic placement of naso-jejunal feeding tube.
  • Patients at risk of pregnancy without effective contraception
  • Evidence or history of drug or alcohol abuse within two years.
  • Unable or unwilling to stop medications influencing upper GI motility
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944593

Locations
Switzerland
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Schweizerischer Nationalfonds
Investigators
Study Director: Innere Medizin: Forschungsgruppe GI-Motility UniversitaetsSpital Zuerich
  More Information

No publications provided

Responsible Party: MFox, Consultant Gastroenterologist, University of Zurich
ClinicalTrials.gov Identifier: NCT00944593     History of Changes
Other Study ID Numbers: SNF 320030-120597
Study First Received: July 20, 2009
Last Updated: April 2, 2012
Health Authority: Switzerland: UZurich

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014