Evaluation of Diagnostic Methods and Dietary Treatment of Diabetic Gastroparesis

Göteborg University

Status and phase: Completed; Phase 2

Conditions: Diabetic Gastroparesis

Treatments: Other: Can the motility be improved; Radiation: Validate X-ray diagnostic method.; Dietary Supplement: dietary treatment: food of small particle size; Biological: postprandial plasma glucose

Study type: Interventional

Funder types: Other

Identifiers

NCT01557296

#EMS-5115#

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

Diabetic diet

Placebo Comparator group

Description:

Control group. Subjects with Insulin Treated Diabetes Mellitus and Gastroparesis. Diet: Food of large particle size during 20 weeks.

Treatment:

Biological: postprandial plasma glucose

Radiation: Validate X-ray diagnostic method.

Dietary Supplement: dietary treatment: food of small particle size

Other: Can the motility be improved

Diet food in small particle size

Active Comparator group

Description:

Intervention group: Subjects with Insulin Treated Diabetes and Gastroparesis. Intervention Diet: Food of small particle size during 20 weeks.

Treatment:

Biological: postprandial plasma glucose

Radiation: Validate X-ray diagnostic method.

Dietary Supplement: dietary treatment: food of small particle size

Other: Can the motility be improved