Condition category
Nutritional, Metabolic, Endocrine
Date applied
07/06/2006
Date assigned
07/06/2006
Last edited
07/06/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Numico Research B.V. (The Netherlands)

Sponsor details

P.O. Box 7005
Wageningen
6700 CA
Netherlands

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes