Evaluation of Diagnostic Methods and Dietary Treatment of Diabetic Gastroparesis

NCT01557296 | Completed Phase 2

• 1 other identifier: #EMS-5115#
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetic Gastroparesis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Metabolic Control - HbA1c

  22 weeks

Secondary Outcomes (1)

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

  22 weeks

Study Arms (2)

Diabetic diet

PLACEBO COMPARATOR

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; Radiation: Validate X-ray diagnostic method.; Other: Can the motility be improved; Biological: postprandial plasma glucose

Diet food in small particle size

ACTIVE COMPARATOR

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; Radiation: Validate X-ray diagnostic method.; Other: Can the motility be improved; Biological: postprandial plasma glucose

Interventions

dietary treatment: food of small particle size DIETARY_SUPPLEMENT

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

Also known as: Randomized study, Diabetic gastroparesis, Dietary treatment:Food of small particle size, Metabolic control, Gastrointestinal symptoms, Quality of life, Nutrition status, Autonomic neuropathy

Diabetic diet; Diet food in small particle size

Validate X-ray diagnostic method. RADIATION

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

Also known as: Radiopaque markers method, Gastric scintigraphy

Diabetic diet; Diet food in small particle size

Can the motility be improved OTHER

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

Also known as: motility, gastric emptying, improved gastric emptying

Diabetic diet; Diet food in small particle size

postprandial plasma glucose BIOLOGICAL

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

Also known as: gastric emptying, plasma glucose response, metabolic control

Diabetic diet; Diet food in small particle size

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diabetes type 1 or 2 and gastroparesis
• must be able to understand oral and verbal instructions

You may not qualify if:

• 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

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Goteborg Universitet, Sahlgrenska Academy, Sahlgrenska University Hospital

Gothenburg, SE 413 45, Sweden

Location

Related Publications (1)

• 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.

  PMID: 24419482 DERIVED

MeSH Terms

Conditions

Gastroparesis; Diabetes Mellitus

Interventions

Quality of Life; Nutritional Status; Cell Movement; Gastric Emptying

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Population Characteristics; Cell Physiological Phenomena; Locomotion; Movement; Gastrointestinal Motility; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Magnus Simrén, M.D., Ph.D.

  Inst of Medicine, Sahlgrenska Academy, Göteborg University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: March 19, 2012
• Study Start: September 1, 2007
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: November 6, 2018

Record last verified: 2018-11

Locations

SE (1)