Evaluation of Diagnostic Methods and Dietary Treatment of Diabetic Gastroparesis

Phase 2

Completed

• Conditions: Diabetic Gastroparesis
• Interventions: Radiation: Validate X-ray diagnostic method.; Other: Can the motility be improved; Biological: postprandial plasma glucose

• Registration Number: NCT01557296
• Lead Sponsor: Göteborg University

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2012-03-16
• Study First Submitted QC: 2012-03-16
• Study First Posted: 2012-03-19
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-05
• Last Update Posted: 2018-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetic diet	Validate X-ray diagnostic method.	Control group. Subjects with Insulin Treated Diabetes Mellitus and Gastroparesis. Diet: Food of large particle size during 20 weeks.
Diabetic diet	Can the motility be improved	Control group. Subjects with Insulin Treated Diabetes Mellitus and Gastroparesis. Diet: Food of large particle size during 20 weeks.
Diabetic diet	postprandial plasma glucose	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	postprandial plasma glucose	Intervention group: Subjects with Insulin Treated Diabetes and Gastroparesis. Intervention Diet: Food of small particle size during 20 weeks.
Diet food in small particle size	Validate X-ray diagnostic method.	Intervention group: Subjects with Insulin Treated Diabetes and Gastroparesis. Intervention Diet: Food of small particle size during 20 weeks.
Diet food in small particle size	Can the motility be improved	Intervention group: Subjects with Insulin Treated Diabetes and Gastroparesis. Intervention Diet: Food of small particle size during 20 weeks.

Primary Outcome Measures

Name	Time	Method
Metabolic Control - HbA1c	22 weeks

Secondary Outcome Measures

Name	Time	Method
gastrointestinal symptoms - Questionnaire: Patient Assessment of upper Gastrointestinal Disorders Symptoms, Gastrointestinal Symptom Rating Scale	22 weeks

Trial Locations

Locations (1)

Goteborg Universitet, Sahlgrenska Academy, Sahlgrenska University Hospital; 🇸🇪 Goteborg, Sweden