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NCT Number: NCT01557296

Evaluation of Diagnostic Methods and Dietary Treatment of Diabetic Gastroparesis

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

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Key information

Conditions

Diabetic Gastroparesis Diabetes Mellitus Digestive System Diseases Endocrine System Diseases Gastrointestinal Diseases Gastroparesis Glucose Metabolism Disorders Metabolic Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Goteborg Universitet, Sahlgrenska Academy, Sahlgrenska University Hospital

Gothenburg, SE 413 45, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dietary treatment: food of small particle size

Dietary Supplement

Subjects with diabetes mellitus and gastroparesis. Insulin treatment. Dietary treatment with food of small particle size.

Other names: Randomized study, Diabetic gastroparesis, Dietary treatment:Food of small particle size, Metabolic control, Gastrointestinal symptoms, Quality of life, Nutrition status, Autonomic neuropathy

Validate X-ray diagnostic method.

Radiation

Follow 20 radiopaque markers throw the ventricle by X-ray.

Other names: Radiopaque markers method, Gastric scintigraphy

Can the motility be improved

Other

Registered the gastric emptying after intervention. Comparing the registrations at the beginning and at the end of the study.

Other names: motility, gastric emptying, improved gastric emptying

postprandial plasma glucose

Biological

Measure the blood glucose response and gastrointestinal symptoms after a test meal

Other names: gastric emptying, plasma glucose response, metabolic control

Primary outcomes

  1. Metabolic Control - HbA1c

    Time frame: 22 weeks

Secondary outcomes

  1. gastrointestinal symptoms - Questionnaire: Patient Assessment of upper Gastrointestinal Disorders Symptoms, Gastrointestinal Symptom Rating Scale

    Time frame: 22 weeks

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Mar 19, 2012
Registry last updated
Nov 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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