Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
10/04/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.numico.com/en/

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

Publication citations

Additional files

Editorial Notes