No registrations found.
ID
Source
Brief title
Health condition
type 2 diabetes
type 2 diabetes patients
plasma glucose profile
tube feed
disease-specific
DM II
Sponsors and support
Intervention
Outcome measures
Primary outcome
Plasma glucose as assessed with the increase from baseline in plasma glucose levels in the t=3-4 hours period
Secondary outcome
- 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
Background summary
In this study the plasma glucose profile of a new disease-specific tube feed for type 2 diabetes patients will be compared to a standard tube feed in 24 ambulant type 2 diabetes patients. The study is performed in 1 centre in the Netherlands.
Study objective
A 4 hour intervention period with the new disease-specific tube feed will result in a better plasma glucose profile as compared to an isocaloric standard tube feed.
Study design
Time points of the outcome: V0 (screening ¨C 3 wks); Day 1 (day 1); Day 2 (4-10 days); FU cal (+ 3 days).
Intervention
Duration of intervention:2 times 4 hours of continuous feeding
Intervention group: Nutrison Advanced Diason Energy HP
Control group: Nutrision Energy MF
Bosrandweg 20
Mirian Lansink
Wageningen 6700 CA
The Netherlands
+31 (0)317 467814
mirian.lansink@danone.com
Bosrandweg 20
Mirian Lansink
Wageningen 6700 CA
The Netherlands
+31 (0)317 467814
mirian.lansink@danone.com
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
- 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
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 | NL3991 |
| NTR-old | NTR4163 |
| Other | Danone Research : NTS.6.C/A |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |