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


- candidate number1960
- NTR NumberNTR584
- ISRCTNISRCTN57864852
- Date ISRCTN created8-mrt-2006
- date ISRCTN requested7-mrt-2006
- Date Registered NTR1-feb-2006
- Secondary IDs100088 
- Public TitleThe effect of nutritional supplementation with a disease specific tube feed on the postprandial plasma glucose reponse in type 2 diabetic patients at baseline and after 6 and 12 weeks of supplementation.
- Scientific TitleThe effect of nutritional supplementation with a disease specific tube feed on the postprandial plasma glucose reponse in type 2 diabetic patients at baseline and after 6 and 12 weeks of supplementation.
- ACRONYMDiaTube trial
- hypothesisUsage of disease specific tube feed will improve glucose control in diabetic patients.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus type 2 (DM type II)
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2006
- planned closingdate1-sep-2006
- Target number of participants58
- InterventionsDuration intervention: 12 weeks.
Intervention group: disease specific tube feed;
Control group: isocaloric standard tube feed.
- Primary outcomePostprandial glucose response.
- Secondary outcome1. 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.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES Tessa Rossenberg, van
- CONTACT for SCIENTIFIC QUERIESDr. Katrien Laere, van
- Sponsor/Initiator Danone Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Danone Research B.V.
- PublicationsN/A
- Brief summaryIn this trial disease specific tube feed will be compared with a standard tube feed on glucose control in diabetic patients.
- Main changes (audit trail)
- RECORD1-feb-2006 - 9-dec-2008


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