type 2 diabetes type 2 diabetes patients plasma glucose profile tube feed disease-specific DM II
Conditions
Interventions
Duration of intervention:2 times 4 hours of continuous feeding
Intervention group: Nutrison Advanced Diason Energy HP
Control group: Nutrision Energy MF
Sponsors
Danone Research ¨C Centre for Specialised Nutrition
Eligibility
Inclusion criteria
Inclusion criteria: - Age/sex: males (age >= 18 yrs) or post-menopausal females - Ambulant type 2 diabetes patients - Diagnosis of type 2 diabetes according to WHO criteria for more than 6 months - BMI 35 kg/m2 - HbA1c <7.5% - Functioning gastrointestinal tract, eligible for tube feeding via a nasogastric tube - A stable and controlled anti-hyperglycaemic therapy with metformin and/or sulfonylureum for at least two months; regimes are expected to remain stable throughout the duration of the study - Willingness to comply with the study protocol, including: - Overnight stay and fast (at least 10 hours) before each study visit - Refrain from alcohol consumption (24h) and intense physical activities (48h) prior to and during the assessments - Not changing dietary and smoking habits for the duration of the study - Written informed consent
Exclusion criteria
Exclusion criteria: - Any gastrointestinal disease that interferes with bowel function and nutritional intake (i.e. diabetes related constipation or diarrhea secondary to neuropathy, diarrhea due to chronic inflammatory bowel disease, gastroparesis, gastrectomy) - Known heart failure, defined by New York Heart Association (NYHA) class IV - Kidney disease, defined by serum creatinine > 160 ¦Ìmol/L (1.8 mg/dL) or requiring dialysis - Hepatic disease, defined by transaminases (ALAT, ASAT, or alkaline phosphatase) levels more than 5 times upper limit of normal - Severe anemia (hemoglobin ¡Ü5 mmol/L or 8 g/dl) - Major infections (requiring antibiotics) within 2 weeks prior to study entry - Concomitant therapy with alpha-glucosidase inhibitors (acarbose), meglitinides, thiazolidinediones, peptide analogues (GLP antagonisten) or insulin - Concomitant therapy with systemic glucocorticoids or within 2 weeks prior to study entry - Concomitant therapy with beta-blockers - Subjects requiring a fibre-free diet - Galactosaemia - Alcohol abuse - History of allergy or intolerance to the study product components (test or control product) - Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements - Participation in any other studies involving investigational or marketed products concomitantly within 6 weeks of study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma glucose as assessed with the increase from baseline in plasma glucose levels in the t=3-4 hours period | — |
Secondary
| Measure | Time frame |
|---|---|
| - Glucose profile as assessed with: o iAUC mean glucose o (delta) peak glucose o difference between max-min glucose value o decline in glucose levels after stop tube feeding o incidence of hyperglycaemia (>10 mmol/L) o incidence of hypoglycaemia (<3.9 mmol/L) o AUC above cut-off lines of 10 mmol/L o AUC beneath cut-off lines of 3.9 mmol/L - Insulin | — |
Contacts
Public ContactMirian Lansink
Danone Research - Centre for Specialised Nutrition Bosrandweg 20
Outcome results
None listed