No registrations found.
ID
Source
Brief title
Health condition
Type 2 diabetic patients in need of nutritional support.
Sponsors and support
P.O. Box 7005
6700 CA Wageningen
Bosrandweg 20
6704 PH Wageningen
The Netherlands
Tel: +31 (0)317 467 800
Fax: +31 (0)317 466 500
P.O. Box 7005
6700 CA Wageningen
Bosrandweg 20
6704 PH Wageningen
The Netherlands
Tel: +31 (0)317 467 800
Fax: +31 (0)317 466 500
Intervention
Outcome measures
Primary outcome
Postprandial glucose response.
Secondary outcome
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.
Background summary
In this trial disease specific sipfeed will be compared with standard sipfeed on glucose control in diabetic patients.
Study objective
Usage of disease specific sip feed will improve glucose control in diabetic patients.
Study design
N/A
Intervention
Duration intervention: 12 weeks
Intervention group: disease specific sipfeed.
Control group: isocaloric standard sipfeed.
P.O. Box 7005
Carlette Rouws
Wageningen 6700 CA
The Netherlands
+31 (0)317 467972
carlette.rouws@numico-research.nl
P.O. Box 7005
Carlette Rouws
Wageningen 6700 CA
The Netherlands
+31 (0)317 467972
carlette.rouws@numico-research.nl
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.
Exclusion criteria
1. Pregnant or lactating woman or woman planning to become pregnant;
2. Usage of a disease specific nutritional supplement within past 4 weeks;
3. Concomitant therapy with systemic glucocorticoids, insulin or anti-diabetic medication other than Metformin or sulfonylureas;
4. Any acute gastrointestinal disease within 2 weeks prior to study entry;
5. Gastrectomy, gastroparesis or other gastric emptying abnormalities;
6. Acute severe heart failure, end stage liver failure or renal failure requiring dialysis;
7. Patients receiving enteral nutrition;
8. Patients with galactosaemia, fructosaemia or patients requiring a fibre free diet;
9. Drug or alcohol abuse;
10. Participation in other trials within 4 weeks of study entry.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL597 |
NTR-old | NTR653 |
Other | : 100015 |
ISRCTN | ISRCTN86065299 |