Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/11/2004
Date assigned
13/01/2005
Last edited
14/12/2006
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 Geoff Ambler

ORCID ID

Contact details

Institute of Endocrinology and Diabetes
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW
2145
Australia
+61 (0)2 9845 3907
geoffa@chw.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2001/054

Study information

Scientific title

Acronym

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

Not specified

Trial type

Treatment

Patient information sheet

Condition

Insulin resistance and obesity

Intervention

Metformin vs placebo (crossover design)

Intervention type

Drug

Phase

Not Specified

Drug names

metformin

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2005

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Children and adolescents age 9-18 with obesity and insulin resistance, pre-type 2 diabetes.

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

01/01/2005

Recruitment end date

31/12/2005

Locations

Countries of recruitment

Australia

Trial participating centre

Institute of Endocrinology and Diabetes
Westmead NSW
2145
Australia

Sponsor information

Organisation

The Children's Hospital, Westmead - Research and Development Office (Australia)

Sponsor details

Locked Bag 4001
Westmead NSW
2145
Australia

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Diabetes Australia Research Trust

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