Gastric vs Jejunal Feeding in Diabetic Gastroparesis

NCT00944593 | Withdrawn Phase 4

• 1 other identifier: SNF 320030-120597
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• Trial with medical device

Conditions

Diabetic Gastroparesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Gastric emptying rate at gastric emptying half time

  120 min

Study Arms (2)

300kcal liquid Nutrient

EXPERIMENTAL

300kcal liquid nutrient delivered by NJ tube over 60 minutes before ingestion of a standard oral liquid nutrient test meal

Dietary Supplement: Jejunal Feed

Normal Saline

PLACEBO COMPARATOR

Normal Saline delivered via NJ tube over 60 minutes ahead of a standard liquid nutrient test meal

Dietary Supplement: Normal Saline

Interventions

Jejunal Feed DIETARY_SUPPLEMENT

Liquid nutrient (Ensure 200ml (300kcal) over 60 minutes) will be delivered by naso-jejunal feeding tube (previously placed by endoscopy)

Also known as: Ensure Vanilla, Abbott

300kcal liquid Nutrient

Normal Saline DIETARY_SUPPLEMENT

200ml Normal Saline 0.9%

Also known as: Normal Saline 0.9%, Baxter

Normal Saline

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• Schweizerischer Nationalfonds: collaborator

Study Sites (1)

Unknown Facility

Zurich, Switzerland

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Innere Medizin: Forschungsgruppe GI-Motility

  UniversitaetsSpital Zuerich

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Gastroenterologist

Study Record Dates

• First Submitted: July 20, 2009
• First Posted: July 23, 2009
• Study Completion: January 1, 2011
• Last Updated: April 3, 2012

Record last verified: 2012-04

Locations

CH (1)