Diabetic GastroparesisPhase 2NCT01557296
Evaluation of Diagnostic Methods and Dietary Treatment of Diabetic Gastroparesis
A Phase 2 study testing dietary treatment: food of small particle size, Validate X-ray diagnostic method. and Can the motility be improved in people with Diabetic Gastroparesis, run by Göteborg University at 1 site in Sweden.
Trial summary
The objective of the study is in subjects with Insulin Treated Diabetes Mellitus type 1 or 2 and gastroparesis: validate radiopaque markers with fluoroscopy with gastric scintigraphy method study the difference of metabolic control including the frequents of hypoglycaemia, gastrointestinal symptoms, quality of life… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Gastroparesis
- What is being tested?
- dietary treatment: food of small particle size, Validate X-ray diagnostic method. and Can the motility be improved
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2007to Mar 2014
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diabetes type 1 or 2 and gastroparesis
- must be able to understand oral and verbal instructions
Who cannot join
- gastrointestinal surgery
- other gastrointestinal disease
- S-Creatinine >150 umol/L
- mental disease
- cerebral disease
- collagen disease
Show all 12Show fewer
- untreated endocrine disease
- anticholinergic drugs
- psychopharmacologic drugs
- opiates
- addiction to drugs as alcohol and narcotics
- vegetarian
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Goteborg Universitet, Sahlgrenska Academy, Sahlgrenska University Hospital
Gothenburg, SE 413 45
About this study
Official title: Comparing Treatment With Food of Small Particle Size and Food of Large Particle Size in Subjects With Diabetic Gastroparesis. Evaluation of Diagnostic Methods. Determination of the Motility of Gastric Emptying After Intervention
The objective of the study is in subjects with Insulin Treated Diabetes Mellitus type 1 or 2 and gastroparesis:
- validate radiopaque markers with fluoroscopy with gastric scintigraphy method
- study the difference of metabolic control including the frequents of hypoglycaemia, gastrointestinal symptoms, quality of life and nutrition state during dietary treatment of food of small particle size compared with food of large particle size
- validate the radiopaque markers method and measurement of the blood glucose and gastrointestinal symptoms after a test meal, against the gastric scintigraphy
- determine if the function of gastric emptying can be improved after intervention
- Conditions
- Diabetic Gastroparesis
- Being tested
- dietary treatment: food of small particle size, Validate X-ray diagnostic method., Can the motility be improved, postprandial plasma glucose
- Keywords
- Diet, Dietary treatment, Particle size, Gastroparesis, Diabetes Mellitus
- Medical subject headings
- Gastroparesis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary treatment: food of small particle sizeDietary supplement
Also called Randomized study, Diabetic gastroparesis, Dietary treatment:Food of small particle size, Metabolic control
Subjects with diabetes mellitus and gastroparesis. Insulin treatment. Dietary treatment with food of small particle size.
Validate X-ray diagnostic method.Radiation
Also called Radiopaque markers method, Gastric scintigraphy
Follow 20 radiopaque markers throw the ventricle by X-ray.
Can the motility be improvedOther
Also called motility, gastric emptying, improved gastric emptying
Registered the gastric emptying after intervention. Comparing the registrations at the beginning and at the end of the study.
postprandial plasma glucoseBiological
Also called gastric emptying, plasma glucose response, metabolic control
Measure the blood glucose response and gastrointestinal symptoms after a test meal
| Study group | Role | What they receive |
|---|---|---|
| Diabetic diet | Placebo comparator | Control group. Subjects with Insulin Treated Diabetes Mellitus and Gastroparesis. Diet: Food of large particle size during 20 weeks. Receives: Dietary Supplement: dietary treatment: food of small particle size; Radiation: Validate X-ray diagnostic method.; Other: Can the motility be improved; Biological: postprandial plasma glucose |
| Diet food in small particle size | Active comparator | Intervention group: Subjects with Insulin Treated Diabetes and Gastroparesis. Intervention Diet: Food of small particle size during 20 weeks. Receives: Dietary Supplement: dietary treatment: food of small particle size; Radiation: Validate X-ray diagnostic method.; Other: Can the motility be improved; Biological: postprandial plasma glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Control - HbA1c
Measured: 22 weeks
Secondary outcomes (1)
gastrointestinal symptoms - Questionnaire: Patient Assessment of upper Gastrointestinal Disorders Symptoms, Gastrointestinal Symptom Rating Scale
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study startSep 2007
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic GastroparesisStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magnus Simrén, M.D., Ph.D., Study chair, Inst of Medicine, Sahlgrenska Academy, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557296
- Sponsor's protocol ID
- #EMS-5115#
- Status last verified
- Nov 2018
- First submitted
- 16 Mar 2012
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Olausson EA, Storsrud S, Grundin H, Isaksson M, Attvall S, Simren M. A small particle size diet reduces upper gastrointestinal symptoms in patients with diabetic gastroparesis: a randomized controlled trial. Am J Gastroenterol. 2014 Mar;109(3):375-85. doi: 10.1038/ajg.2013.453. Epub 2014 Jan 14.
PubMed 24419482
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Treatment With Food of Small Particle Size and Food of Large Particle Size in Subjects With Diabetic Gastroparesis. Evaluation of Diagnostic Methods. Determination of the Motility of Gastric Emptying After Intervention
- ClinicalTrials.gov ID
- NCT01557296
- Acronym / sponsor ID
- #EMS-5115#
- Conditions
- Diabetic Gastroparesis
- Keywords
- Diet, Dietary treatment, Particle size, Gastroparesis, Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Sep 2007 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 19 Mar 2012 (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.
The objective of the study is in subjects with Insulin Treated Diabetes Mellitus type 1 or 2 and gastroparesis:
- validate radiopaque markers with fluoroscopy with gastric scintigraphy method
- study the difference of metabolic control including the frequents of hypoglycaemia, gastrointestinal symptoms, quality of life and nutrition state during dietary treatment of food of small particle size compared with food of large particle size
- validate the radiopaque markers method and measurement of the blood glucose and gastrointestinal symptoms after a test meal, against the gastric scintigraphy
- determine if the function of gastric emptying can be improved after intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic diet | Placebo comparator | Dietary Supplement: dietary treatment: food of small particle size, Radiation: Validate X-ray diagnostic method., Other: Can the motility be improved, Biological: postprandial plasma glucoseControl group. Subjects with Insulin Treated Diabetes Mellitus and Gastroparesis. Diet: Food of large particle size during 20 weeks. |
| Diet food in small particle size | Active comparator | Dietary Supplement: dietary treatment: food of small particle size, Radiation: Validate X-ray diagnostic method., Other: Can the motility be improved, Biological: postprandial plasma glucoseIntervention group: Subjects with Insulin Treated Diabetes and Gastroparesis. Intervention Diet: Food of small particle size during 20 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diabetes type 1 or 2 and gastroparesis
- must be able to understand oral and verbal instructions
Key exclusion criteria (12 listed)
- gastrointestinal surgery
- other gastrointestinal disease
- S-Creatinine >150 umol/L
- mental disease
- cerebral disease
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 |
|---|---|---|
| dietary treatment: food of small particle sizeAlso: Randomized study, Diabetic gastroparesis, Dietary treatment:Food of small particle size, Metabolic controlSubjects with diabetes mellitus and gastroparesis. Insulin treatment. Dietary treatment with food of small particle size. | Dietary supplement | Diabetic diet, Diet food in small particle size |
| Validate X-ray diagnostic method.Also: Radiopaque markers method, Gastric scintigraphyFollow 20 radiopaque markers throw the ventricle by X-ray. | Radiation | Diabetic diet, Diet food in small particle size |
| Can the motility be improvedAlso: motility, gastric emptying, improved gastric emptyingRegistered the gastric emptying after intervention. Comparing the registrations at the beginning and at the end of the study. | Other | Diabetic diet, Diet food in small particle size |
| postprandial plasma glucoseAlso: gastric emptying, plasma glucose response, metabolic controlMeasure the blood glucose response and gastrointestinal symptoms after a test meal | Biological | Diabetic diet, Diet food in small particle size |
Primary outcome
Metabolic Control - HbA1c
Time frame: 22 weeks
1 secondary outcome
gastrointestinal symptoms - Questionnaire: Patient Assessment of upper Gastrointestinal Disorders Symptoms, Gastrointestinal Symptom Rating Scale
Time frame: 22 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Derived from this study: PubMed 24419482Olausson EA, Storsrud S, Grundin H, Isaksson M, Attvall S, Simren M. A small particle size diet reduces upper gastrointestinal symptoms in patients with diabetic gastroparesis: a randomized controlled trial. Am J Gastroenterol. 2014 Mar;109(3):375-85. doi: 10.1038/ajg.2013.453. Epub 2014 Jan 14.
Related trials for Diabetic Gastroparesis
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
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To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
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
Diabetic Gastroparesis
Recruiting
Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes
Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
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.
Magnus Simrén, M.D., Ph.D. study chair
Inst of Medicine, Sahlgrenska Academy, Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dietary treatment: food of small particle size, Validate X-ray diagnostic method. and Can the motility be improved in people with Diabetic Gastroparesis, run by Göteborg University at 1 site in Sweden.
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 2 inclusion and 12 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: finished, as of the sponsor's last update on 6 Nov 2018. 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 Sweden. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Metabolic Control - HbA1c (time frame: 22 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01557296, which also lists 1 linked publication.
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 6 Nov 2018.