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Evaluation of Diagnostic Methods and Dietary Treatment of Diabetic Gastroparesis

This study is currently recruiting participants.
Verified April 2013 by Göteborg University
Sponsor:
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT01557296
First received: March 16, 2012
Last updated: April 5, 2013
Last verified: April 2013
History of Changes

March 16, 2012
April 5, 2013
September 2007
December 2013   (final data collection date for primary outcome measure)
Metabolic Control - HbA1c [ Time Frame: 22 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01557296 on ClinicalTrials.gov Archive Site
gastrointestinal symptoms - Questionnaire: Patient Assessment of upper Gastrointestinal Disorders Symptoms, Gastrointestinal Symptom Rating Scale [ Time Frame: 22 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Evaluation of Diagnostic Methods and Dietary Treatment of Diabetic Gastroparesis
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

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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Diabetic Gastroparesis
  • 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.
    Other Names:
    • Randomized study
    • Diabetic gastroparesis
    • Dietary treatment:Food of small particle size
    • Metabolic control
    • Gastrointestinal symptoms
    • Quality of life
    • Nutrition status
    • Autonomic neuropathy
  • Radiation: Validate X-ray diagnostic method.
    Follow 20 radiopaque markers throw the ventricle by X-ray.
    Other Names:
    • Radiopaque markers method
    • Gastric scintigraphy
  • 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.
    Other Names:
    • motility
    • gastric emptying
    • improved gastric emptying
  • Biological: postprandial plasma glucose
    Measure the blood glucose response and gastrointestinal symptoms after a test meal
    Other Names:
    • gastric emptying
    • plasma glucose response
    • metabolic control
  • Placebo Comparator: Diabetic diet
    Control group. Subjects with Insulin Treated Diabetes Mellitus and Gastroparesis. Diet: Food of large particle size during 20 weeks.
    Interventions:
    • Dietary Supplement: dietary treatment: food of small particle size
    • Radiation: Validate X-ray diagnostic method.
    • Other: Can the motility be improved
    • Biological: postprandial plasma glucose
  • Active Comparator: Diet food in small particle size
    Intervention group: Subjects with Insulin Treated Diabetes and Gastroparesis. Intervention Diet: Food of small particle size during 20 weeks.
    Interventions:
    • Dietary Supplement: dietary treatment: food of small particle size
    • Radiation: Validate X-ray diagnostic method.
    • Other: Can the motility be improved
    • Biological: postprandial plasma glucose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
June 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: E A Olausson, postgrad stu +46 31 342 26 56 eva.a.olausson@vgregion.se
Sweden
 
NCT01557296
#EMS-5115#
No
Göteborg University
Göteborg University
Not Provided
Study Chair: Magnus Simrén, M.D., Ph.D. Inst of Medicine, Sahlgrenska Academy, Göteborg University
Göteborg University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP