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

ISRCTN	ISRCTN86065299
DOI	https://doi.org/10.1186/ISRCTN86065299
Protocol serial number	100015, NL597, NTR653
Sponsor	Numico Research B.V. (The Netherlands)
Funder	Numico Research B.V.

Submission date: 07/06/2006
Registration date: 07/06/2006
Last edited: 08/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Carlette Rouws
Scientific

Numico Research B.V.
P.O. Box 7005
Wageningen
6700 CA
Netherlands

Phone	+31 (0)31 7467972
Email	carlette.rouws@numico-research.nl

Study information

Primary study design	Interventional
Study design	Randomized controlled trial
Secondary study design	Randomised controlled trial
Scientific title	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
Study acronym	DiaDrink trial
Study objectives	Usage of disease-specific sip feed will improve glucose control in diabetic patients.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Postprandial glucose response.
Key secondary outcome measure(s)	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
Completion date	01/09/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	34
Total final enrolment	40
Key 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
Key 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
Date of first enrolment	15/12/2005
Date of final enrolment	01/09/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

Numico Research B.V.

Wageningen
6700 CA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2008	08/01/2021	Yes	No

Editorial Notes

08/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.