No registrations found.
ID
Source
Brief title
Health condition
Diabetes Mellitus type 2 (DM type II)
Sponsors and support
Intervention
Outcome measures
Primary outcome
HbA1c
Secondary outcome
1. 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
Background summary
In this trial disease-specific formula will be compared with an isocarloric standard enteral formula with fibre on HbA1c in diabetic patients.
Study objective
To 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.
Intervention
Duration intervention: 12 weeks Intervention group: diabetic specific enteral formula Control group: isocaloric standard enteral formula with fibre
P.O. Box 75538
M. Vries, de
Amsterdam 1118 ZN
The Netherlands
+31 (0)317 467800
Miranda.deVries@numico-research.nl
P.O. Box 75538
M. Vries, de
Amsterdam 1118 ZN
The Netherlands
+31 (0)317 467800
Miranda.deVries@numico-research.nl
Inclusion criteria
1. 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 ¡Ü BMI ¡Ü 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 criteria
1. 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
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 | NL757 |
| NTR-old | NTR768 |
| Other | : N/A |
| ISRCTN | ISRCTN32726656 |