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Evaluation of Diagnostic Methods and Dietary Treatment of Diabetic Gastroparesis

NCT01557296 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-11-06

No results posted yet for this study

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

  • Diabetic Gastroparesis

Interventions

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

Sponsors & Collaborators

  • Göteborg University

    lead OTHER

Principal Investigators

  • Magnus Simrén, M.D., Ph.D. · Inst of Medicine, Sahlgrenska Academy, Göteborg University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01557296 on ClinicalTrials.gov