Status:
WITHDRAWN
Gastric vs Jejunal Feeding in Diabetic Gastroparesis
Lead Sponsor:
University of Zurich
Collaborating Sponsors:
Schweizerischer Nationalfonds
Conditions:
Diabetic Gastroparesis
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
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 a...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00944593
End Date
January 1 2011
Last Update
April 3 2012
Active Locations (1)
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1
Zurich, Switzerland