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van CCT (UK)

van CCT (UK)

ESPRIT study

- candidate number15380
- NTR NumberNTR4163
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-sep-2013
- Secondary IDsNTS.6.C/A Danone Research
- Public TitleESPRIT study
- Scientific TitleEffect of a new disease-specific tube feed on the plasma glucose profile in type 2 diabetes patients.
- hypothesisA 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.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II), Diabetes Mellitus
- 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 mol/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 5 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 12-sep-2013
- planned closingdate31-dec-2013
- Target number of participants24
- InterventionsDuration of intervention:2 times 4 hours of continuous feeding
Intervention group: Nutrison Advanced Diason Energy HP
Control group: Nutrision Energy MF
- Primary outcomePlasma 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
- TimepointsTime points of the outcome: V0 (screening C 3 wks); Day 1 (day 1); Day 2 (4-10 days); FU cal (+ 3 days).
- Trial web siteN/A
- statusinclusion stopped: follow-up
- Sponsor/Initiator Nutricia Research Centre for Specialised Nutrition
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Research - Centre for Specialised Nutrition
- PublicationsN/A
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD6-sep-2013 - 26-mrt-2014

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