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
Protocol serial number	NL757 (NTR768)
Sponsor	Numico Research B.V. (The Netherlands)
Funder	Numico Research B.V. (The Netherlands)

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

Primary study design	Interventional
Study design	Randomised controlled, parallel group, double blinded, multicentre trial
Secondary study design	Randomised controlled trial
Scientific title	Effect of a new disease-specific enteral formula on metabolic control in type two diabetic patients
Study acronym	Diacarb trial
Study objectives	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(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) studied	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
Primary outcome measure(s)	HbA1c
Key secondary outcome measure(s)	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
Completion date	01/09/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	140
Key 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
Key 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
Date of first enrolment	01/11/2006
Date of final enrolment	01/09/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Numico Research B.V.

Amsterdam
1118 ZN
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Editorial Notes

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