Evaluation of Diagnostic Methods and Dietary Treatment of Diabetic Gastroparesis

November 5, 2018 updated by: Göteborg University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Goteborg, Sweden, SE 413 45
        • Goteborg Universitet, Sahlgrenska Academy, Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Quality of life
  • Metabolic control
  • Randomized study
  • Diabetic gastroparesis
  • Dietary treatment:Food of small particle size
  • Gastrointestinal symptoms
  • 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:
  • Quality of life
  • Metabolic control
  • Randomized study
  • Diabetic gastroparesis
  • Dietary treatment:Food of small particle size
  • Gastrointestinal symptoms
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Metabolic Control - HbA1c
Time Frame: 22 weeks
22 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
gastrointestinal symptoms - Questionnaire: Patient Assessment of upper Gastrointestinal Disorders Symptoms, Gastrointestinal Symptom Rating Scale
Time Frame: 22 weeks
22 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Investigators

  • Study Chair: Magnus Simrén, M.D., Ph.D., Inst of Medicine, Sahlgrenska Academy, Göteborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2007

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

March 16, 2012

First Submitted That Met QC Criteria

March 16, 2012

First Posted (Estimate)

March 19, 2012

Study Record Updates

Last Update Posted (Actual)

November 6, 2018

Last Update Submitted That Met QC Criteria

November 5, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #EMS-5115#

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Gastroparesis

Clinical Trials on dietary treatment: food of small particle size

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe