Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/03/2006
Date assigned
08/03/2006
Last edited
24/08/2009
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 Tessa Rossenberg, van

ORCID ID

Contact details

Numico Research
P.O. Box 7005
Wageningen
6700 CA
Netherlands
+31 (0)317 467805
tessa.vanrossenberg@numico-research.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR584; 100088

Study information

Scientific title

Acronym

DiaTube trial

Study hypothesis

Usage of disease specific tube feed will improve glucose control in diabetic patients.

Ethics approval

Received from local medical ethics committee

Study design

Multicentre randomised double blind active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Diabetes mellitus type II (DM type II)

Intervention

Duration intervention: 12 weeks
Intervention group: disease specific tube feed
Control group: isocaloric standard tube feed

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Postprandial glucose response

Secondary outcome measures

1. Glycaemic control before and after 6 and 12 weeks of supplementation
2. Fasting plasma lipid profile before and after 6 and 12 weeks of supplementation

Overall trial start date

01/01/2006

Overall trial end date

01/09/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis type 2 diabetes
2. Age >18
3. HbA1c between 6.5%-8.5%
4. In need of nutritional support by tube feeding for at least 12 weeks
5. Functioning gastrointestinal (GI) tract, eligible for tube feeding
6. Nutrition via percutaneous endoscopic gastrostomy (PEG) or nasogastric tube
7. Having given written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

58

Participant exclusion criteria

1. Pregnant or lactating women or women planning to become pregnant
2. Usage of a disease specific tube feed within past 4 weeks
3. Acute severe heart failure, end stage liver failure or renal failure requiring dialysis;
4. Any acute gastrointestinal disease within past 2 weeks
5. Concomitant therapy with glucocorticoids or acarbose
6. Nutrition via percutaneous endoscopic jejunostomy (PEJ)
7. Drug or alcohol abuse
8. Participation in other trials within four weeks of study entry

Recruitment start date

01/01/2006

Recruitment end date

01/09/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Numico Research
Wageningen
6700 CA
Netherlands

Sponsor information

Organisation

Numico Research B.V. (The Netherlands)

Sponsor details

P.O. Box 7005
Wageningen
6700 CA
Netherlands

Sponsor type

Not defined

Website

Funders

Funder type

Industry

Funder name

Numico Research B.V. (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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19501937

Publication citations

  1. Results

    Vaisman N, Lansink M, Rouws CH, van Laere KM, Segal R, Niv E, Bowling TE, Waitzberg DL, Morley JE, Tube feeding with a diabetes-specific feed for 12 weeks improves glycaemic control in type 2 diabetes patients., Clin Nutr, 2009, 28, 5, 549-555, doi: 10.1016/j.clnu.2009.05.004.

Additional files

Editorial Notes