Evaluation of Diagnostic Methods and Dietary Treatment of Diabetic Gastroparesis

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Göteborg University
Sponsor:
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT01557296
First received: March 16, 2012
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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

Condition Intervention Phase
Diabetic Gastroparesis
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
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • Metabolic Control - HbA1c [ Time Frame: 22 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • gastrointestinal symptoms - Questionnaire: Patient Assessment of upper Gastrointestinal Disorders Symptoms, Gastrointestinal Symptom Rating Scale [ Time Frame: 22 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: September 2007
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Diabetic diet
Control group. Subjects with Insulin Treated Diabetes Mellitus and Gastroparesis. Diet: Food of large particle size during 20 weeks.
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
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.
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01557296

Contacts
Contact: E A Olausson, postgrad stu +46 31 342 26 56 eva.a.olausson@vgregion.se

Locations
Sweden
Goteborg Universitet, Sahlgrenska Academy, Sahlgrenska University Hospital Recruiting
Goteborg, Sweden, SE 413 45
Contact: E A Olausson, postgraduate    + 46 31 342 26 56    eva.a.olausson@vgregion.se   
Contact: M Simrén, M.D., Ph.D.    +46 31 342 10 00    magnus.simren@medicine.gu.se   
Principal Investigator: E A Olausson, postgraduate         
Sponsors and Collaborators
Göteborg University
Investigators
Study Chair: Magnus Simrén, M.D., Ph.D. Inst of Medicine, Sahlgrenska Academy, Göteborg University
  More Information

No publications provided by Göteborg University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01557296     History of Changes
Other Study ID Numbers: #EMS-5115#
Study First Received: March 16, 2012
Last Updated: June 25, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Göteborg University:
Diet
Dietary treatment
Particle size
Gastroparesis
Diabetes Mellitus

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014