Type 2 diabetic patients that are not capable of eating and/or drinking sufficiently and are in need of nutritional support with tube feeding to meet their energy requirements.
Conditions
Interventions
Duration intervention: 12 weeks.
Intervention group: disease specific tube feed
Control group: isocaloric standard tube feed.
Sponsors
Numico Research B.V.
P.O. Box 7005
6700 CA Wageningen, The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis type 2 diabetes; 2. Age > 18; 3. HbA1c between 6.5%-8.5%; 4. In need for nutritional support by tube feeding for at least 12 weeks; 5. Functioning GI tract, eligible for tube feeding; 6. Nutrition via PEG or nasogastric tube; 7. Having given written informed consent.
Exclusion criteria
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 ver 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 PEJ; 7. Drug or alcohol abuse; 8. Participation in other trials within four weeks of study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postprandial glucose response. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Glycaemic control before and after 6 and 12 weeks of supplementation; 2. Fasting plasma lipid profile before and after 6 and 12 weeks of supplementation. | — |
Contacts
Public ContactTessa Rossenberg, van
Numico Research P.O. Box 7005
Outcome results
None listed