Trials / Completed
CompletedNCT01557296
Evaluation of Diagnostic Methods and Dietary Treatment of Diabetic Gastroparesis
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Göteborg University · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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 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
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | dietary treatment: food of small particle size | Subjects with diabetes mellitus and gastroparesis. Insulin treatment. Dietary treatment with food of small particle size. |
| RADIATION | Validate X-ray diagnostic method. | Follow 20 radiopaque markers throw the ventricle by X-ray. |
| OTHER | Can the motility be improved | Registered the gastric emptying after intervention. Comparing the registrations at the beginning and at the end of the study. |
| BIOLOGICAL | postprandial plasma glucose | Measure the blood glucose response and gastrointestinal symptoms after a test meal |
Timeline
- Start date
- 2007-09-01
- Primary completion
- 2014-03-01
- Completion
- 2014-03-01
- First posted
- 2012-03-19
- Last updated
- 2018-11-06
Locations
1 site across 1 country: Sweden
Source: ClinicalTrials.gov record NCT01557296. Inclusion in this directory is not an endorsement.