Evaluation of Diagnostic Methods and Dietary Treatment of Diabetic Gastroparesis
NCT ID: NCT01557296
Last Updated: 2018-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2007-09-30
2014-03-31
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Diabetic diet
Control group. Subjects with Insulin Treated Diabetes Mellitus and Gastroparesis. Diet: Food of large particle size during 20 weeks.
dietary treatment: food of small particle size
Subjects with diabetes mellitus and gastroparesis. Insulin treatment. Dietary treatment with food of small particle size.
Validate X-ray diagnostic method.
Follow 20 radiopaque markers throw the ventricle by X-ray.
Can the motility be improved
Registered the gastric emptying after intervention. Comparing the registrations at the beginning and at the end of the study.
postprandial plasma glucose
Measure the blood glucose response and gastrointestinal symptoms after a test meal
Diet food in small particle size
Intervention group: Subjects with Insulin Treated Diabetes and Gastroparesis. Intervention Diet: Food of small particle size during 20 weeks.
dietary treatment: food of small particle size
Subjects with diabetes mellitus and gastroparesis. Insulin treatment. Dietary treatment with food of small particle size.
Validate X-ray diagnostic method.
Follow 20 radiopaque markers throw the ventricle by X-ray.
Can the motility be improved
Registered the gastric emptying after intervention. Comparing the registrations at the beginning and at the end of the study.
postprandial plasma glucose
Measure the blood glucose response and gastrointestinal symptoms after a test meal
Interventions
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dietary treatment: food of small particle size
Subjects with diabetes mellitus and gastroparesis. Insulin treatment. Dietary treatment with food of small particle size.
Validate X-ray diagnostic method.
Follow 20 radiopaque markers throw the ventricle by X-ray.
Can the motility be improved
Registered the gastric emptying after intervention. Comparing the registrations at the beginning and at the end of the study.
postprandial plasma glucose
Measure the blood glucose response and gastrointestinal symptoms after a test meal
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* must be able to understand oral and verbal instructions
Exclusion Criteria
* other gastrointestinal disease
* S-Creatinine \>150 umol/L
* mental disease
* cerebral disease
* collagen disease
* untreated endocrine disease
* anticholinergic drugs
* psychopharmacologic drugs
* opiates
* addiction to drugs as alcohol and narcotics
* vegetarian
18 Years
70 Years
ALL
No
Sponsors
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Göteborg University
OTHER
Responsible Party
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Principal Investigators
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Magnus Simrén, M.D., Ph.D.
Role: STUDY_CHAIR
Inst of Medicine, Sahlgrenska Academy, Göteborg University
Locations
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Goteborg Universitet, Sahlgrenska Academy, Sahlgrenska University Hospital
Gothenburg, , Sweden
Countries
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References
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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.
Other Identifiers
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#EMS-5115#
Identifier Type: -
Identifier Source: org_study_id
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