Contact information
Type
Scientific
Primary contact
Dr M de Vries
ORCID ID
Contact details
Numico Research B.V.
Postbus 75538
Amsterdam
1118 ZN
Netherlands
+31 (0)31 746 7800
Miranda.deVries@numico-research.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Diacarb trial
Study hypothesis
To determine the effect on HbA1c of a disease-specific enteral formula compared to an isocaloric standard enteral formula (control) in type two diabetic patients after 12 weeks of supplementation.
Ethics approval
Approval received from the local ethics board (Stichting beoordeling Ethiek Biomedisch Onderzoek [BEBO]) on the 3rd April 2007 (ref: X115).
Study design
Randomised controlled, parallel group, double blinded, multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Diabetes Mellitus type two (DM type II)
Intervention
Duration intervention: 12 weeks
Intervention group: diabetic specific enteral formula
Control group: isocaloric standard enteral formula with fibre
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
HbA1c
Secondary outcome measures
1. Fasting plasma glucose
2. Fasting plasma insulin
3. Fructosamine
4. Fasting plasma lipid profile:
a. Triglycerides
b. Total cholesterol
c. Low Density Lipoprotein (LDL)
d. High Density Lipoprotein (HDL)
5. Fasting Free fatty Acids (FFA)
6. Total daily insulin requirement
7. Insulin sensitivity by HOmeostatic Model Assessment (HOMA-IR)
8. Incidence of skin, pulmonary and urinary tract infections
9. Fasting (hs) C-Reactive Protein (CRP)
10. Fasting pro-inflammatory cytokines: Interleukin -6 (IL-6), Interleukin-8 (IL-8), and Tumour Necrotising Factor (TNF)
11. Fasting Plasminogen Activator inhibitor-1 activity (PAI-1)
12. Blood pressure
13. Tolerance
Overall trial start date
01/11/2006
Overall trial end date
01/09/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Type two diabetic patients
2. Diagnosis of type two diabetes according to World Health Organisation (WHO) criteria for more than six months
3. Aged over 18
4. Hospitalised patients, patients in nursing homes or home-care patients
5. HbA1c between 6.1% and 10,5% (including 6.1% and 10.5%)
6. Body Mass Index (BMI) between 18 kg/m^2 and 35 kg/m^2
7. Indication for tube feeding for at least six weeks
8. Functioning GastroIntestinal (GI) tract, eligible for tube feeding
9. Nutrition via Percutaneous Endoscopic Gastrostomy (PEG) or nasogastric tube
10. Willing to comply with the study protocol
11. Signed informed consent
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
140
Participant exclusion criteria
1. Any gastrointestinal disease that interferes with bowel function and nutritional intake (i.e. diabetes related constipation/diarrhoea secondary to neuropathy, diarrhoea due to chronic inflammatory bowel disease, gastroparesis, gastrectomy)
2. Concomitant intake of parenteral nutrition or other clinical enteral nutrition
3. Significant heart (New York Heart Association [NYHA] class IV), hepatic (transaminase more than three times normal) or renal disease (requiring dialysis)
4. Concomitant therapy with acarbose
5. Concomitant therapy with systemic glucocorticoids or within two 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 four weeks of study entry
Recruitment start date
01/11/2006
Recruitment end date
01/09/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Numico Research B.V.
Amsterdam
1118 ZN
Netherlands
Sponsor information
Organisation
Numico Research B.V. (The Netherlands)
Sponsor details
P.O. Box 7005
Wageningen
6700 CA
Netherlands
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Numico Research B.V. (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary