Type 2 diabetic patients in need of nutritional support.
Conditions
Interventions
Duration intervention: 12 weeks
Intervention group: disease specific sipfeed.
Control group: isocaloric standard sipfeed.
Sponsors
Numico Research B.V.
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
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Postprandial glucose response. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactCarlette Rouws
Numico Research B.V., P.O. Box 7005
Outcome results
None listed