No registrations found.
ID
Source
Brief title
Health condition
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.
Sponsors and support
P.O. Box 7005
6700 CA Wageningen, The Netherlands
P.O. Box 7005
6700 CA Wageningen, The Netherlands
Intervention
Outcome measures
Primary outcome
Postprandial glucose response.
Secondary outcome
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.
Background summary
In this trial disease specific tube feed will be compared with a standard tube feed on glucose control in diabetic patients.
Study objective
Usage of disease specific tube feed will improve glucose control in diabetic patients.
Study design
N/A
Intervention
Duration intervention: 12 weeks.
Intervention group: disease specific tube feed;
Control group: isocaloric standard tube feed.
P.O. Box 7005
Tessa Rossenberg, van
Wageningen 6700 CA
The Netherlands
+31 (0)317 467805
tessa.vanrossenberg@numico-research.nl
P.O. Box 7005
Tessa Rossenberg, van
Wageningen 6700 CA
The Netherlands
+31 (0)317 467805
tessa.vanrossenberg@numico-research.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL540 |
| NTR-old | NTR584 |
| Other | : 100088 |
| ISRCTN | ISRCTN57864852 |