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The effect of a disease-specific supplement on the postprandial plasma glucose response in type 2 diabetic patients at baseline and after 6 and 12 weeks of supplementation.


- candidate number2056
- NTR NumberNTR653
- ISRCTNISRCTN86065299
- Date ISRCTN created7-jun-2006
- date ISRCTN requested16-mei-2006
- Date Registered NTR12-apr-2006
- Secondary IDs100015 
- Public TitleThe effect of a disease-specific supplement on the postprandial plasma glucose response in type 2 diabetic patients at baseline and after 6 and 12 weeks of supplementation.
- Scientific TitleThe effect of a disease-specific supplement on the postprandial plasma glucose response in type 2 diabetic patients at baseline and after 6 and 12 weeks of supplementation.
- ACRONYMDiaDrink trial
- hypothesisUsage of disease specific sip 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. Anti-diabetic therapy: Metformin and/or sulfonylureas;
5. In need of nutritional support;
6. Capable of using oral drink feed supplementation;
7. On a stable and controlled anti-diabetic regime for at least one month;
8. Signed informed consent.
- Exclusion criteria1. Pregnant or lactating woman or woman planning to become pregnant;
2. Usage of a disease specific nutritional supplement within past 4 weeks;
3. Concomitant therapy with systemic glucocorticoids, insulin or anti-diabetic medication other than Metformin or sulfonylureas;
4. Any acute gastrointestinal disease within 2 weeks prior to study entry;
5. Gastrectomy, gastroparesis or other gastric emptying abnormalities;
6. Acute severe heart failure, end stage liver failure or renal failure requiring dialysis;
7. Patients receiving enteral nutrition;
8. Patients with galactosaemia, fructosaemia or patients requiring a fibre free diet;
9. Drug or alcohol abuse;
10. Participation in other trials within 4 weeks of study entry.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-dec-2005
- planned closingdate1-sep-2006
- Target number of participants34
- InterventionsDuration intervention: 12 weeks Intervention group: disease specific sipfeed.
Control group: isocaloric standard sipfeed.
- 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
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES Carlette Rouws
- 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.
- PublicationsDiabetes Res Clin Pract. 2008 Apr;80(1):75-82. Epub 2007 Dec 11.
- Brief summaryIn this trial disease specific sipfeed will be compared with standard sipfeed on glucose control in diabetic patients.
- Main changes (audit trail)
- RECORD12-apr-2006 - 2-dec-2008


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