Contact information
Type
Scientific
Primary contact
Ms Carlette Rouws
ORCID ID
Contact details
Numico Research B.V.
P.O. Box 7005
Wageningen
6700 CA
Netherlands
+31 (0)31 7467972
carlette.rouws@numico-research.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
100015
Study information
Scientific title
Acronym
DiaDrink trial
Study hypothesis
Usage of disease-specific sip feed will improve glucose control in diabetic patients.
Ethics approval
Not provided at time of registration
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Diabetes Mellitus type II (DM type II)
Intervention
Duration intervention: 12 weeks
Intervention group: disease-specific sip feed.
Control group: isocaloric standard sip feed.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Postprandial glucose response.
Secondary outcome measures
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
Overall trial start date
15/12/2005
Overall trial end date
01/09/2006
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
34
Participant exclusion criteria
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
Recruitment start date
15/12/2005
Recruitment end date
01/09/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Numico Research B.V.
Wageningen
6700 CA
Netherlands
Funders
Funder type
Industry
Funder name
Numico Research B.V.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary