Condition category
Nutritional, Metabolic, Endocrine
Date applied
03/10/2002
Date assigned
03/10/2002
Last edited
05/09/2007
Prospective/Retrospective
Prospectively 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 Thomas Linn

ORCID ID

Contact details

Clinical Research Unit
3rd Medical Clinic and Policlinic
Justus Liebig University
Giessen
Rodthohl 6
D-35385
Germany
+49 (0)641 99 42841
thomas.linn@innere.med.uni-giessen.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

1. Under consideration of baseline data the difference of C-peptide levels between patients under intensive therapy and conventional therapy depends on the willingness of the patients to take part in such a clinical study
2. The failure rate of intensive therapy is less than the rate of conventional therapy

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Type 1 diabetes mellitus

Intervention

Conventional or intensive insulin therapy

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2003

Overall trial end date

01/01/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men or women aged 18 - 40 years at diagnosis
2. Established Type-1 Diabetes diagnosed up to three months ago
3. Consent to participate in a diabetes training programme
4. Informed consent before enrolment

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

1. History of neuropathy, nephropathy, and retinopathy of other than diabetes related origin
2. Negative C-peptide level at diagnosis
3. History of psychiatric disease or drug or alc ohol abuse
4. Treatment with oral antidiabetic medication
5. Subject unlikely to comply with the protocol (e.g. inability or unwillingness to participate adequate training or to complete diaries appropriately) or to understand the nature and the scope of the study

Recruitment start date

01/01/2003

Recruitment end date

01/01/2005

Locations

Countries of recruitment

Germany

Trial participating centre

Clinical Research Unit
Giessen, Rodthohl 6
D-35385
Germany

Sponsor information

Organisation

Justus Liebig University (Germany)

Sponsor details

-
Giessen Rodthohl 6
D-35385
Germany

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Justus Liebig University (Germany)

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

Protocol in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=14667244

Publication citations

  1. Protocol

    Linn T, Mann M, Mann M, Bretzel RG, Boedeker RH, Randomised prospective study for the effect of therapy on residual beta cell function in type-1 diabetes mellitus [ISRCTN70703138]., BMC Endocr Disord, 2003, 3, 1, 5, doi: 10.1186/1472-6823-3-5.

Additional files

Editorial Notes