The effect of nutritional supplementation with a disease specific tube feed on the postprandial plasma glucose response in type 2 diabetic patients at baseline and after 6 and 12 weeks of supplementation
| ISRCTN | ISRCTN57864852 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57864852 |
| Protocol serial number | NTR584; 100088 |
| Sponsor | Numico Research B.V. (The Netherlands) |
| Funder | Numico Research B.V. (Netherlands) |
- Submission date
- 08/03/2006
- Registration date
- 08/03/2006
- Last edited
- 24/08/2009
- 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
Dr Tessa Rossenberg, van
Scientific
Scientific
Numico Research
P.O. Box 7005
Wageningen
6700 CA
Netherlands
| Phone | +31 (0)317 467805 |
|---|---|
| tessa.vanrossenberg@numico-research.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised double blind active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | DiaTube trial |
| Study objectives | Usage of disease specific tube feed will improve glucose control in diabetic patients. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Diabetes mellitus type II (DM type II) |
| Intervention | Duration intervention: 12 weeks Intervention group: disease specific tube feed Control group: isocaloric standard tube 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 |
| 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 | 58 |
| Key inclusion criteria | 1. Diagnosis type 2 diabetes 2. Age >18 3. HbA1c between 6.5%-8.5% 4. In need of nutritional support by tube feeding for at least 12 weeks 5. Functioning gastrointestinal (GI) tract, eligible for tube feeding 6. Nutrition via percutaneous endoscopic gastrostomy (PEG) or nasogastric tube 7. Having given written informed consent |
| Key exclusion criteria | 1. Pregnant or lactating women or women planning to become pregnant 2. Usage of a disease specific tube feed within past 4 weeks 3. Acute severe heart failure, end stage liver failure or renal failure requiring dialysis; 4. Any acute gastrointestinal disease within past 2 weeks 5. Concomitant therapy with glucocorticoids or acarbose 6. Nutrition via percutaneous endoscopic jejunostomy (PEJ) 7. Drug or alcohol abuse 8. Participation in other trials within four weeks of study entry |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 01/09/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Numico Research
Wageningen
6700 CA
Netherlands
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 | 01/10/2009 | Yes | No |
