Diabetic GastroparesisPhase 4NCT00944593
Gastric vs Jejunal Feeding in Diabetic Gastroparesis
A Phase 4 study testing Jejunal Feed and Normal Saline in people with Diabetic Gastroparesis, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Diabetic Gastroparesis
- What is being tested?
- Jejunal Feed and Normal Saline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- Start not givento Jan 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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:
- Effects on GI symptoms and function to gastric distension in fasted and fed states
- Effects on GI symptoms and function to oral vs. nasogastric delivery of a test meal
- 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
- Conditions
- Diabetic Gastroparesis
- Being tested
- Jejunal Feed, Normal Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jejunal FeedDietary supplement
Also called Ensure Vanilla, Abbott
Liquid nutrient (Ensure 200ml (300kcal) over 60 minutes) will be delivered by naso-jejunal feeding tube (previously placed by endoscopy)
Normal SalineDietary supplement
Also called Normal Saline 0.9%, Baxter
200ml Normal Saline 0.9%
| Study group | Role | What they receive |
|---|---|---|
| 300kcal liquid Nutrient | Experimental | 300kcal liquid nutrient delivered by NJ tube over 60 minutes before ingestion of a standard oral liquid nutrient test meal Receives: 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 Receives: Dietary Supplement: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After administration of test meal
Secondary outcomes (1)
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")
Measured: 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study completionJan 2011
Why it stopped: Principle Investigator moved to another institution. Research funds transferred. Study to be performed at new institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic GastroparesisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Schweizerischer Nationalfonds
- Responsible party
- Principal investigator, MFox, University of Zurich
- Investigators
- Innere Medizin: Forschungsgruppe GI-Motility, Study director, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944593
- Sponsor's protocol ID
- SNF 320030-120597
- Status last verified
- Apr 2012
- First submitted
- 20 Jul 2009
- Last updated
- 3 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00944593
- Acronym / sponsor ID
- SNF 320030-120597
- Conditions
- Diabetic Gastroparesis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principle Investigator moved to another institution. Research funds transferred. Study to be performed at new institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Schweizerischer Nationalfonds
- Study completion
- Jan 2011
- First posted
- 23 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Effects on GI symptoms and function to gastric distension in fasted and fed states
- Effects on GI symptoms and function to oral vs. nasogastric delivery of a test meal
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 300kcal liquid Nutrient | Experimental | Dietary Supplement: Jejunal Feed300kcal liquid nutrient delivered by NJ tube over 60 minutes before ingestion of a standard oral liquid nutrient test meal |
| Normal Saline | Placebo comparator | Dietary Supplement: Normal SalineNormal Saline delivered via NJ tube over 60 minutes ahead of a standard liquid nutrient test meal |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jejunal FeedAlso: Ensure Vanilla, AbbottLiquid nutrient (Ensure 200ml (300kcal) over 60 minutes) will be delivered by naso-jejunal feeding tube (previously placed by endoscopy) | Dietary supplement | 300kcal liquid Nutrient |
| Normal SalineAlso: Normal Saline 0.9%, Baxter200ml Normal Saline 0.9% | Dietary supplement | Normal Saline |
Primary outcome
Improvement in symptoms of gastroparesis (GCSI score)
Time frame: After administration of test meal
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.
1 secondary outcome
Gastric emptying rate at gastric emptying half time
Time frame: 120 min
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2012.
Related trials for Diabetic Gastroparesis
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Type 1 Diabetes, Gastroparesis Due to Diabetes Mellitus Type I
Active, not recruiting
Impact of Per Oral Pyloromyotomy (POP) on Glycemic Control in Diabetes
Diabetes Mellitus, Gastroparesis With Diabetes Mellitus
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Washed Microbiota Transplantation for Diabetic Gastroparesis
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Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Innere Medizin: Forschungsgruppe GI-Motility study director
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Jejunal Feed and Normal Saline in people with Diabetic Gastroparesis, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in symptoms of gastroparesis (GCSI score) (time frame: After administration of test meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2012.