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 |
| Secondary identifying numbers | 100015, NL597, NTR653 |
- 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
Scientific
Numico Research B.V.
P.O. Box 7005
Wageningen
6700 CA
Netherlands
| Phone | +31 (0)31 7467972 |
|---|---|
| carlette.rouws@numico-research.nl |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 15/12/2005 |
| Completion date | 01/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
6700 CA
Netherlands
Sponsor information
Numico Research B.V. (The Netherlands)
University/education
University/education
P.O. Box 7005
Wageningen
6700 CA
Netherlands
"ROR" |
https://ror.org/00aj77a24 |
|---|
Funders
Funder type
Industry
Numico Research B.V.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
