Type 2 diabetic patients Diabetes mellitus, sip feed Suikerziekte, drinkvoeding
Conditions
Interventions
Duration intervention:
Single dose with 200 mL commercially available high fat diabetes-specific sip feed at Day 1 (high fat control product) followed by a 4 week intervention period (Day 8 -36) inc
Sponsors
Numico Research B.V.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ambulant type 2 diabetic patient 2. Diagnosis of type 2 diabetes according to WHO criteria for more than six months 3. Male (age > 18 years at V0) or post-menopausal female 4. 6.5% „T HbA1c „T 8.0% 5. 18.0 kg/m2 < BMI < 32.0 kg/m2 6. On a stable and controlled anti-diabetic therapy for at least two months with Metformin and/or sulfonylureas: regimes are expected to remain stable throughout the duration of the study 7. If lipid-lowering drugs are used, their use should be stable and controlled for at least two months and expected to remain stable throughout the duration of the study 8. Willing to comply with the study protocol 9. Signed informed consent before any study related assessment
Exclusion criteria
Exclusion criteria: 1. On a weight loss diet 2. Any gastrointestinal disease that interferes with bowel function and nutritional intake (i.e. diabetes related constipation or diarrhoea secondary to neuropathy, diarrhoea due to chronic inflammatory bowel disease, gastroparesis, gastrectomy) 3. Significant heart (NYHA class IV), hepatic (transaminase greater than 3 times upper limit of normal), renal disease (requiring dialysis or serum creatinine > 160 µmol/L) 4. Infection requiring antibiotics within 3 weeks prior to study entry 5. Concomitant therapy with insulin or oral anti-diabetic medication other than Metformin and / or sulfonylureas 6. Concomitant therapy with systemic glucocorticoids or within 2 weeks prior to study entry 7. Galactosaemia 8. Lactose intolerance 9. Requiring a fibre-free diet 10. Alcohol abuse 11. Fever 12. Investigator¡¦s uncertainty about the willingness or ability of the patient to comply with the protocol requirements 13. Participation in other intervention studies within 4 weeks of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postprandial glucose response determined at Day 8 and Day 36 | — |
Secondary
| Measure | Time frame |
|---|---|
| Postprandial TG response determined at Day 1 and Day 8 Gastrointestinal tolerance measured by questionnaire | — |
Contacts
Public ContactL. Vendrig
Julius Centrum voor Gezondheidswetenschappen en Eerstelijns Geneeskunde
Outcome results
None listed