The effect of nutritional supplementation with a disease specific tube feed on the postprandial plasma glucose response in type 2 diabetic patients at baseline and after 6 and 12 weeks of supplementatio

Completed

• Conditions: Diabetes mellitus type II (DM type II); Nutritional, Metabolic, Endocrine; Non-insulin dependent diabetes

• Registration Number: ISRCTN57864852
• Lead Sponsor: umico Research B.V. (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-08
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

1. Diagnosis type 2 diabetes
2. Age >18
3. HbA1c between 6.5%-8.5%
4. In need of nutritional support by tube feeding for at least 12 weeks
5. Functioning gastrointestinal (GI) tract, eligible for tube feeding
6. Nutrition via percutaneous endoscopic gastrostomy (PEG) or nasogastric tube
7. Having given written informed consent

Exclusion Criteria

1. Pregnant or lactating women or women planning to become pregnant
2. Usage of a disease specific tube feed within past 4 weeks
3. Acute severe heart failure, end stage liver failure or renal failure requiring dialysis;
4. Any acute gastrointestinal disease within past 2 weeks
5. Concomitant therapy with glucocorticoids or acarbose
6. Nutrition via percutaneous endoscopic jejunostomy (PEJ)
7. Drug or alcohol abuse
8. Participation in other trials within four weeks of study entry

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postprandial glucose response

Secondary Outcome Measures

Name	Time	Method
1. Glycaemic control before and after 6 and 12 weeks of supplementation<br>2. Fasting plasma lipid profile before and after 6 and 12 weeks of supplementation