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The objective of the study is in subjects with Insulin Treated Diabetes Mellitus type 1 or 2 and gastroparesis:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetic diet | Placebo Comparator | Control 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 | Intervention group: Subjects with Insulin Treated Diabetes and Gastroparesis. Intervention Diet: Food of small particle size during 20 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dietary treatment: food of small particle size | Dietary Supplement | Subjects with diabetes mellitus and gastroparesis. Insulin treatment. Dietary treatment with food of small particle size. |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic Control - HbA1c | 22 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| gastrointestinal symptoms - Questionnaire: Patient Assessment of upper Gastrointestinal Disorders Symptoms, Gastrointestinal Symptom Rating Scale | 22 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magnus Simrén, M.D., Ph.D. | Inst of Medicine, Sahlgrenska Academy, Göteborg University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Goteborg Universitet, Sahlgrenska Academy, Sahlgrenska University Hospital | Gothenburg | SE 413 45 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24419482 | Derived | 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. |
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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| ID | Term |
|---|---|
| D011788 | Quality of Life |
| D009752 | Nutritional Status |
| D002465 | Cell Movement |
| D005746 | Gastric Emptying |
| ID | Term |
|---|---|
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
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|
| Validate X-ray diagnostic method. | Radiation | Follow 20 radiopaque markers throw the ventricle by X-ray. |
|
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| Can the motility be improved | Other | Registered the gastric emptying after intervention. Comparing the registrations at the beginning and at the end of the study. |
|
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| postprandial plasma glucose | Biological | Measure the blood glucose response and gastrointestinal symptoms after a test meal |
|
|
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D004778 |
| Environment and Public Health |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D011154 | Population Characteristics |
| D002468 | Cell Physiological Phenomena |
| D008124 | Locomotion |
| D009068 | Movement |
| D005769 | Gastrointestinal Motility |
| D004068 | Digestive System Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |