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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01557296

Enrollment

Registered

2012-03-19

Start date

2007-09-30

Completion date

2014-03-31

Last updated

2018-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Gastroparesis

Keywords

Diet, Dietary treatment, Particle size, Gastroparesis, Diabetes Mellitus

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

Interventions

DIETARY_SUPPLEMENTdietary treatment: food of small particle size

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

RADIATIONValidate X-ray diagnostic method.

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

OTHERCan the motility be improved

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

BIOLOGICALpostprandial plasma glucose

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Metabolic Control - HbA1c	22 weeks

Secondary

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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026