Effect of a new disease-specific enteral formula on metabolic control in type two diabetic patients

Not Applicable

Completed

• Conditions: Diabetes Mellitus type two (DM type II); Nutritional, Metabolic, Endocrine; Diabetes mellitus

• Registration Number: ISRCTN32726656
• Lead Sponsor: umico Research B.V. (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-12-28
• Study Completion: 2008-09-01
• Last Update Posted: 4 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 140

Inclusion Criteria

1. Type two diabetic patients
2. Diagnosis of type two diabetes according to World Health Organisation (WHO) criteria for more than six months
3. Aged over 18
4. Hospitalised patients, patients in nursing homes or home-care patients
5. HbA1c between 6.1% and 10,5% (including 6.1% and 10.5%)
6. Body Mass Index (BMI) between 18 kg/m^2 and 35 kg/m^2
7. Indication for tube feeding for at least six weeks
8. Functioning GastroIntestinal (GI) tract, eligible for tube feeding
9. Nutrition via Percutaneous Endoscopic Gastrostomy (PEG) or nasogastric tube
10. Willing to comply with the study protocol
11. Signed informed consent

Exclusion Criteria

1. Any gastrointestinal disease that interferes with bowel function and nutritional intake (i.e. diabetes related constipation/diarrhoea secondary to neuropathy, diarrhoea due to chronic inflammatory bowel disease, gastroparesis, gastrectomy)
2. Concomitant intake of parenteral nutrition or other clinical enteral nutrition
3. Significant heart (New York Heart Association [NYHA] class IV), hepatic (transaminase more than three times normal) or renal disease (requiring dialysis)
4. Concomitant therapy with acarbose
5. Concomitant therapy with systemic glucocorticoids or within two weeks prior to study entry
6. Nutrition via any tube that has to be placed into the jejunum
7. Galactosaemia
8. Alcohol abuse
9. Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
10. Participation in other studies within four weeks of study entry

Study & Design

• Study Type: Interventional
• Study Design: Not specified