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Effect of a new disease-specific enteral formula on metabolic control in type 2 diabetic patients.


- candidate number2243
- NTR NumberNTR768
- ISRCTNISRCTN32726656
- Date ISRCTN created28-dec-2006
- date ISRCTN requested18-dec-2006
- Date Registered NTR12-sep-2006
- Secondary IDsN/A 
- Public TitleEffect of a new disease-specific enteral formula on metabolic control in type 2 diabetic patients.
- Scientific TitleEffect of a new disease-specific enteral formula on metabolic control in type 2 diabetic patients.
- ACRONYMDiacarb trial
- hypothesisTo determine the effect on HbA1c of a disease-specific enteral formula compared to an isocaloric standard enteral formula (control) in type 2 diabetic patients after 12 weeks of supplementation.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II)
- Inclusion criteria1. Type 2 diabetic patients
2. Diagnosis of type 2 diabetes according to WHO criteria for more than 6 months
3. Age >18
4. Hospitalised patients, patients in nursing homes or home-care patients
5. HbA1c between 6.1%-10,5% (including 6,1% and 10.5%)
6. 18 kg/m2 BMI 35 kg/m2
7. Indication for tube feeding for at least 6 weeks
8. Functioning GI tract, eligible for tube feeding
9. Nutrition via PEG or nasogastric tube
10. Willing to comply with the study protocol
11. Signed informed consent
- Exclusion criteria1. Any gastrointestinal disease that interferes with bowel function and nutritional intake (i.e. diabetes related constipation/diarrhea secondary to neuropathy, diarrhea due to chronic inflammatory bowel disease, gastroparesis, gastrectomy)
2. Concomitant intake of parenteral nutrition or other clinical enteral nutrition
3. Significant heart (NYHA class IV), hepatic (transaminase more than 3 times normal) or renal disease (requiring dialysis)
4. Concomitant therapy with acarbose
5. Concomitant therapy with systemic glucocorticoids or within 2 weeks prior to study entry
6. Nutrition via any tube that has to be placed into the jejunum
7. Galactosaemia
8. Alcohol abuse
9. Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
10. Participation in other studies within 4 weeks of study entry
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-nov-2006
- planned closingdate1-sep-2008
- Target number of participants140
- InterventionsDuration intervention: 12 weeks Intervention group: diabetic specific enteral formula Control group: isocaloric standard enteral formula with fibre
- Primary outcomeHbA1c
- Secondary outcome1. Fasting plasma glucose
2. Fasting plasma insulin
3. Fructosamine
4. Fasting plasma lipid profile:
Triglycerides, Total cholesterol, LDL, HDL
5. Fasting free fatty acids (FFA)
6. Total daily insulin requirement
7. Insulin sensitivity by HOMA-IR
8. Incidence of skin, pulmonary and urinary tract infections
9. Fasting (hs) CRP
10. Fasting pro-inflammatory cytokines: IL-6, IL-8, IL-18, and TNF-
11. Fasting plasminogen activator inhibitor-1 activity (PAI-1)
12. Blood pressure
13. Tolerance
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES M. Vries, de
- CONTACT for SCIENTIFIC QUERIESDr. Katrien Laere, van
- 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 formula will be compared with an isocarloric standard enteral formula with fibre on HbA1c in diabetic patients.
- Main changes (audit trail)
- RECORD12-sep-2006 - 29-dec-2006


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