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
Scientific
Numico Research B.V.
Postbus 75538
Amsterdam
1118 ZN
Netherlands
| Phone | +31 (0)31 746 7800 |
|---|---|
| Miranda.deVries@numico-research.nl |
Study information
| Study design | Randomised controlled, parallel group, double blinded, multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 01/11/2006 |
| Completion date | 01/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 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
1118 ZN
Netherlands
Sponsor information
Numico Research B.V. (The Netherlands)
Industry
Industry
P.O. Box 7005
Wageningen
6700 CA
Netherlands
| Website | http://www.numico.com/en/ |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
22/09/2021: Proactive update review. No publications found. Search options exhausted.
