Gastric vs Jejunal Feeding in Diabetic Gastroparesis

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

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

Study Overview

• Status: Withdrawn
• Conditions: Diabetic Gastroparesis
• Intervention / Treatment: Dietary supplement: Jejunal Feed; Dietary supplement: Normal Saline

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Normal Saline 0.9%, Baxter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in symptoms of gastroparesis (GCSI score)	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.	After administration of test meal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric emptying rate at gastric emptying half time	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")	120 min

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Schweizerischer Nationalfonds
• Investigators: Study Director: Innere Medizin: Forschungsgruppe GI-Motility, Universitaetsspital Zuerich

Study record dates

Study Major Dates

• Study Completion: January 1, 2011

Study Registration Dates

• First Submitted: July 20, 2009
• First Submitted That Met QC Criteria: July 21, 2009
• First Posted (Estimate): July 23, 2009

Study Record Updates

• Last Update Posted (Estimate): April 3, 2012
• Last Update Submitted That Met QC Criteria: April 2, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis
• Other Study ID Numbers: SNF 320030-120597