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Evaluation of Diagnostic Methods and Dietary Treatment of Diabetic Gastroparesis

Primary Purpose

Diabetic Gastroparesis

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
dietary treatment: food of small particle size
Validate X-ray diagnostic method.
Can the motility be improved
postprandial plasma glucose
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Gastroparesis focused on measuring Diet, Dietary treatment, Particle size, Gastroparesis, Diabetes Mellitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Goteborg Universitet, Sahlgrenska Academy, Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Diabetic diet

Diet food in small particle size

Arm Description

Control group. Subjects with Insulin Treated Diabetes Mellitus and Gastroparesis. Diet: Food of large particle size during 20 weeks.

Intervention group: Subjects with Insulin Treated Diabetes and Gastroparesis. Intervention Diet: Food of small particle size during 20 weeks.

Outcomes

Primary Outcome Measures

Metabolic Control - HbA1c

Secondary Outcome Measures

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

Full Information

First Posted
March 16, 2012
Last Updated
November 5, 2018
Sponsor
Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT01557296
Brief Title
Evaluation of Diagnostic Methods and Dietary Treatment of Diabetic Gastroparesis
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 2007 (Actual)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Gastroparesis
Keywords
Diet, Dietary treatment, Particle size, Gastroparesis, Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diabetic diet
Arm Type
Placebo Comparator
Arm Description
Control group. Subjects with Insulin Treated Diabetes Mellitus and Gastroparesis. Diet: Food of large particle size during 20 weeks.
Arm Title
Diet food in small particle size
Arm Type
Active Comparator
Arm Description
Intervention group: Subjects with Insulin Treated Diabetes and Gastroparesis. Intervention Diet: Food of small particle size during 20 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
dietary treatment: food of small particle size
Other Intervention Name(s)
Randomized study, Diabetic gastroparesis, Dietary treatment:Food of small particle size, Metabolic control, Gastrointestinal symptoms, Quality of life, Nutrition status, Autonomic neuropathy
Intervention Description
Subjects with diabetes mellitus and gastroparesis. Insulin treatment. Dietary treatment with food of small particle size.
Intervention Type
Radiation
Intervention Name(s)
Validate X-ray diagnostic method.
Other Intervention Name(s)
Radiopaque markers method, Gastric scintigraphy
Intervention Description
Follow 20 radiopaque markers throw the ventricle by X-ray.
Intervention Type
Other
Intervention Name(s)
Can the motility be improved
Other Intervention Name(s)
motility, gastric emptying, improved gastric emptying
Intervention Description
Registered the gastric emptying after intervention. Comparing the registrations at the beginning and at the end of the study.
Intervention Type
Biological
Intervention Name(s)
postprandial plasma glucose
Other Intervention Name(s)
gastric emptying, plasma glucose response, metabolic control
Intervention Description
Measure the blood glucose response and gastrointestinal symptoms after a test meal
Primary Outcome Measure Information:
Title
Metabolic Control - HbA1c
Time Frame
22 weeks
Secondary Outcome Measure Information:
Title
gastrointestinal symptoms - Questionnaire: Patient Assessment of upper Gastrointestinal Disorders Symptoms, Gastrointestinal Symptom Rating Scale
Time Frame
22 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magnus Simrén, M.D., Ph.D.
Organizational Affiliation
Inst of Medicine, Sahlgrenska Academy, Göteborg University
Official's Role
Study Chair
Facility Information:
Facility Name
Goteborg Universitet, Sahlgrenska Academy, Sahlgrenska University Hospital
City
Goteborg
ZIP/Postal Code
SE 413 45
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
24419482
Citation
Olausson EA, Storsrud S, Grundin H, Isaksson M, Attvall S, Simren M. A small particle size diet reduces upper gastrointestinal symptoms in patients with diabetic gastroparesis: a randomized controlled trial. Am J Gastroenterol. 2014 Mar;109(3):375-85. doi: 10.1038/ajg.2013.453. Epub 2014 Jan 14.
Results Reference
derived

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Evaluation of Diagnostic Methods and Dietary Treatment of Diabetic Gastroparesis

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