Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
21/04/2011
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 Richard Paisey

ORCID ID

Contact details

South Devon Health Care NHS Trust
Torbay Hospital
Lawes Bridge
Torquay
TQ2 7AA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0224145780

Study information

Scientific title

Acronym

Study hypothesis

Does group education compared to practice care show better patient compliance, glycaemic control weight loss/control in newly diagnosed type II diabetic patients?

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

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Nutritional, Metabolic, Endocrine: Diabetes

Intervention

Group education compared to practice care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Patient compliance, glycaemic and weight control. Sustainable knowledge and lifestyle changes.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

10/06/1998

Overall trial end date

30/03/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Newly diagnosed type II non insulin dependant diabetic patients.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Added December 2008: 99

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

10/06/1998

Recruitment end date

30/03/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

South Devon Health Care NHS Trust
Torquay
TQ2 7AA
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

South Devon Healthcare NHS Trust (UK)

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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16409560

Publication citations

  1. Results

    Daly ME, Paisey R, Paisey R, Millward BA, Eccles C, Williams K, Hammersley S, MacLeod KM, Gale TJ, Short-term effects of severe dietary carbohydrate-restriction advice in Type 2 diabetes--a randomized controlled trial., Diabet. Med., 2006, 23, 1, 15-20, doi: 10.1111/j.1464-5491.2005.01760.x.

Additional files

Editorial Notes