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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01557296
Other study ID # #EMS-5115#
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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