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

ISRCTN ISRCTN32726656
DOI https://doi.org/10.1186/ISRCTN32726656
Secondary identifying numbers NL757 (NTR768)
Submission date
28/12/2006
Registration date
28/12/2006
Last edited
22/09/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M de Vries
Scientific

Numico Research B.V.
Postbus 75538
Amsterdam
1118 ZN
Netherlands

Phone +31 (0)31 746 7800
Email Miranda.deVries@numico-research.nl

Study information

Study designRandomised controlled, parallel group, double blinded, multicentre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleEffect of a new disease-specific enteral formula on metabolic control in type two diabetic patients
Study acronymDiacarb trial
Study objectivesTo 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(s)Approval received from the local ethics board (Stichting beoordeling Ethiek Biomedisch Onderzoek [BEBO]) on the 3rd April 2007 (ref: X115).
Health condition(s) or problem(s) studiedDiabetes Mellitus type two (DM type II)
InterventionDuration intervention: 12 weeks
Intervention group: diabetic specific enteral formula
Control group: isocaloric standard enteral formula with fibre
Intervention typeOther
Primary outcome measureHbA1c
Secondary outcome measures1. 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 study start date01/11/2006
Completion date01/09/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants140
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/11/2006
Date of final enrolment01/09/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Numico Research B.V.
Amsterdam
1118 ZN
Netherlands

Sponsor information

Numico Research B.V. (The Netherlands)
Industry

P.O. Box 7005
Wageningen
6700 CA
Netherlands

Website http://www.numico.com/en/
ROR logo "ROR" https://ror.org/00aj77a24

Funders

Funder type

Industry

Numico Research B.V. (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

22/09/2021: Proactive update review. No publications found. Search options exhausted.