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Effect of a diabetes-specific sip feed on the postprandial glucose response in type 2 diabetic patients


- candidate number3150
- NTR NumberNTR1264
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-mrt-2008
- Secondary IDsDia.2.C/H 
- Public TitleEffect of a diabetes-specific sip feed on the postprandial glucose response in type 2 diabetic patients
- Scientific TitleEffect of a diabetes-specific sip feed on the postprandial glucose response in type 2 diabetic patients
- ACRONYMMetCon
- hypothesisUsage of disease specific sip feed will improve glucose control in diabetic patients.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II), Glucose levels , Sip feed
- Inclusion criteria1. 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 criteria1. 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. Investigatorˇ¦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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2008
- planned closingdate31-dec-2008
- Target number of participants44
- InterventionsDuration 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) including intake of either 200 mL diabetes-specific sip feed (test product) twice daily or 200 mL isocaloric standard sip feed (control product) twice daily. At the start of the study and at the start and end of the 4 week intervention period blood samples will be drawn for determination of blood glucose levels (primary parameter at Day 8 and 36) and blood triglyceride levels (secondary parameter at Day 1 and 8).
During the trial questionnaire have to be filled in at 4 periods of 4 consecutive days to analyze gastrointestinal tolerance to the test and control product.
- Primary outcomePostprandial glucose response determined at Day 8 and Day 36
- Secondary outcomePostprandial TG response determined at Day 1 and Day 8
Gastrointestinal tolerance measured by questionnaire
- TimepointsScreening; Day 1: determination of blood TG levels;
Day 8: determination of blood TG and glucose levels;
Day 36: determination of blood glucose levels;
Days 4-7, 8-11, 22-25 and 32-35:
gastrointestinal tolerance questionnaires
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMw. L. Vendrig
- CONTACT for SCIENTIFIC QUERIES Mirian Lansink
- Sponsor/Initiator Danone Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Danone Research B.V.
- PublicationsN/A
- Brief summaryIn this trial disease-specific sip feed will be compared with standard fibre enriched sip feed on glucose control and with high-fat disease-specific sip feed on triglyceride control in diabetic patients. The disease-specific sip feed will be compared with standard fibre enriched sip feed on gastrointestinal tolerance during a 4-week supplementation period.
- Main changes (audit trail)
- RECORD28-mrt-2008 - 16-sep-2010


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