Evaluation of Diagnostic Methods and Dietary Treatment of Diabetic Gastroparesis

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Diabetic Gastroparesis

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diabetes type 1 or 2 and gastroparesis must be able to understand oral and verbal instructions Exclusion Criteria: gastrointestinal surgery 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Diabetic diet<br>Control group. Subjects with Insulin Treated Diabetes Mellitus and Gastroparesis. Diet: Food of large particle size during 20 weeks. | Dietary Supplement: dietary treatment: food of small particle size<br>* Subjects with diabetes mellitus and gastroparesis. Insulin treatment. Dietary treatment with food of small particle size.<br>* Other names: Autonomic neuropathy;Radiation: Validate X-ray diagnostic method.<br>* Follow 20 radiopaque markers throw the ventricle by X-ray.<br>* Other names: Gastric scintigraphy;Other: Can the motility be improved<br>* Registered the gastric emptying after intervention. Comparing the registrations at the beginning and at the end of the study.<br>* Other names: improved gastric emptying;Biological: postprandial plasma glucose<br>* Measure the blood glucose response and gastrointestinal symptoms after a test meal<br>* Other names: metabolic control;|
| Active Comparator: Diet food in small particle size<br>Intervention group: Subjects with Insulin Treated Diabetes and Gastroparesis. Intervention Diet: Food of small particle size during 20 weeks. | Dietary Supplement: dietary treatment: food of small particle size<br>* Subjects with diabetes mellitus and gastroparesis. Insulin treatment. Dietary treatment with food of small particle size.<br>* Other names: Autonomic neuropathy;Radiation: Validate X-ray diagnostic method.<br>* Follow 20 radiopaque markers throw the ventricle by X-ray.<br>* Other names: Gastric scintigraphy;Other: Can the motility be improved<br>* Registered the gastric emptying after intervention. Comparing the registrations at the beginning and at the end of the study.<br>* Other names: improved gastric emptying;Biological: postprandial plasma glucose<br>* Measure the blood glucose response and gastrointestinal symptoms after a test meal<br>* Other names: metabolic control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic Control - HbA1c |  | 22 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gastrointestinal symptoms - Questionnaire: Patient Assessment of upper Gastrointestinal Disorders Symptoms, Gastrointestinal Symptom Rating Scale |  | 22 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet, Dietary treatment, Particle size, Gastroparesis, Diabetes Mellitus