Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/02/2002
Date assigned
27/02/2002
Last edited
06/09/2007
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 Anne Benedicte Juul

ORCID ID

Contact details

Copenhagen Trial Unit
Centre for Clinical Intervention Research
H:S Rigshospitalet
Dept 7102
Copenhagen Ø
DK-2100
Denmark
+45 3545 7156 or +45 3526 7235
Anne.j@ctu.rh.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Not Applicable

Study information

Scientific title

Acronym

DIPOM

Study hypothesis

Not provided at time of registration

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Diabetes mellitus and major surgery

Intervention

Diabetic patients undergoing major noncardiac surgery are randomised to 7 days of perioperative beta blocking (Metoprolol CR/XL [SeloZok®] 100 mg daily) versus placebo treatment.

Intervention type

Drug

Phase

Not Specified

Drug names

Metoprolol CR/XL

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/2000

Overall trial end date

01/07/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Patients 40 years of age with diabetes undergoing noncardiac major (lasting more than 1 hour) surgery

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/07/2000

Recruitment end date

01/07/2002

Locations

Countries of recruitment

Denmark

Trial participating centre

Copenhagen Trial Unit
Copenhagen Ø
DK-2100
Denmark

Sponsor information

Organisation

Copenhagen Trial Unit (Denmark)

Sponsor details

Centre for Clinical Intervention Research
H:S Rigshospitalet
Dept 7102
Copenhagen Ø
DK-2100
Denmark

Sponsor type

Research organisation

Website

Funders

Funder type

Charity

Funder name

The Danish Heart Foundation (Denmark) (ref: 01-2-5-51A-22931)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Danish Diabetes Foundation (Denmark) (ref: C.1)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Copenhagen Hospital Corporation's Research Council (Denmark) (ref: 109/01)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Programme for Strengthening Regional Collaboration within Medical Health Research (Denmark) (ref: 301-070-5199)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

AstraZeneca (Denmark) (ref: AD-MET-0003)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

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

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=16793810

Publication citations

  1. Results

    Juul AB, Wetterslev J, Gluud C, Kofoed-Enevoldsen A, Jensen G, Callesen T, Nørgaard P, Fruergaard K, Bestle M, Vedelsdal R, Miran A, Jacobsen J, Roed J, Mortensen MB, Jørgensen L, Jørgensen J, Rovsing ML, Petersen PL, Pott F, Haas M, Albret R, Nielsen LL, Johansson G, Stjernholm P, Mølgaard Y, Foss NB, Elkjaer J, Dehlie B, Boysen K, Zaric D, Munksgaard A, Madsen JB, Øberg B, Khanykin B, Blemmer T, Yndgaard S, Perko G, Wang LP, Winkel P, Hilden J, Jensen P, Salas N, , Effect of perioperative beta blockade in patients with diabetes undergoing major non-cardiac surgery: randomised placebo controlled, blinded multicentre trial., BMJ, 2006, 332, 7556, 1482, doi: 10.1136/bmj.332.7556.1482.

Additional files

Editorial Notes