Evaluation of Diagnostic Methods and Dietary Treatment of Diabetic Gastroparesis

Diabetic Gastroparesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01557296
• Other study ID #: #EMS-5115#
• Status: Completed
• Phase: Phase 2
• Start date: September 2007
• Est. completion date: March 2014

Study information

• Verified date: November 2018
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Gastroparesis
• Gastroparesis

Intervention

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

Locations

Country	Name	City	State
Sweden	Goteborg Universitet, Sahlgrenska Academy, Sahlgrenska University Hospital	Goteborg

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic Control - HbA1c		22 weeks
Secondary	gastrointestinal symptoms - Questionnaire: Patient Assessment of upper Gastrointestinal Disorders Symptoms, Gastrointestinal Symptom Rating Scale		22 weeks