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ISRCTN
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ISRCTN86065299
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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DiaDrink trial
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Serial number at source
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100015
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Study hypothesis
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Usage of disease-specific sip feed will improve glucose control in diabetic patients.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomized controlled 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. 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
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Participants - exclusion criteria
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1. Pregnant or lactating woman or woman planning to become pregnant
2. Usage of a disease-specific nutritional supplement within past four weeks
5. Concomitant therapy with systemic glucocorticoids, insulin or anti-diabetic medication other than metformin or sulfonylureas
6. Any acute gastrointestinal disease within two weeks prior to study entry
7. Gastrectomy, gastroparesis or other gastric emptying abnormalities
8. Acute severe heart failure, end stage liver failure or renal failure requiring dialysis
9. Patients receiving enteral nutrition
10. Patients with galactosaemia, fructosaemia or patients requiring a fibre-free diet
11. Drug or alcohol abuse
12. Participation in other trials within 4 weeks of study entry
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Anticipated start date
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15/12/2005
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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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34
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Interventions
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Duration intervention: 12 weeks
Intervention group: disease-specific sip feed.
Control group: isocaloric standard sip 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.
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Trial website
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Publications
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Contact name
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Ms
Carlette
Rouws
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Address
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Numico Research B.V.
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)31 7467972
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Fax
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+31 (0)31 7466500
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Email
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carlette.rouws@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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07/06/2006
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Last edited
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07/06/2006
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Date ISRCTN assigned
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07/06/2006
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