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ISRCTN
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ISRCTN57864852
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ClinicalTrials.gov identifier
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Public title
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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 supplementation
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Scientific title
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Acronym
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DiaTube trial
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Serial number at source
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NTR584; 100088
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Study hypothesis
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Usage of disease specific tube feed will improve glucose control in diabetic patients.
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Lay summary
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Ethics approval
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Received from local medical ethics committee
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Study design
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Multicentre randomised double blind active controlled parallel group trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Diabetes mellitus type II (DM type II)
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/01/2006
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Anticipated end date
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01/09/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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58
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Interventions
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Duration intervention: 12 weeks
Intervention group: disease specific tube feed
Control group: isocaloric standard tube feed
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Primary outcome measure(s)
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Postprandial glucose response
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Secondary outcome measure(s)
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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
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Sources of funding
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Numico Research B.V. (Netherlands)
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Trial website
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Publications
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2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19501937
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Contact name
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Dr
Tessa
Rossenberg, van
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Address
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Numico Research
P.O. Box 7005
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City/town
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Wageningen
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Zip/Postcode
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6700 CA
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Country
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Netherlands
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Tel
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+31 (0)317 467805
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Email
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tessa.vanrossenberg@numico-research.nl
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Sponsor
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Numico Research B.V. (The Netherlands)
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Address
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P.O. Box 7005
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City/town
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Wageningen
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Zip/Postcode
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6700 CA
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Country
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Netherlands
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Date applied
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08/03/2006
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Last edited
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24/08/2009
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Date ISRCTN assigned
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08/03/2006
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