Insulin resistance and obesity in adolescents - metabolic characterisation and effects of therapeutic intervention with metformin

ISRCTN ISRCTN43267711
DOI https://doi.org/10.1186/ISRCTN43267711
Secondary identifying numbers 2001/054
Submission date
16/11/2004
Registration date
13/01/2005
Last edited
12/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Geoff Ambler
Scientific

Institute of Endocrinology and Diabetes
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW
2145
Australia

Phone +61 (0)2 9845 3907
Email geoffa@chw.edu.au

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleInsulin resistance and obesity in adolescents - metabolic characterisation and effects of therapeutic intervention with metformin
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedInsulin resistance and obesity
InterventionMetformin vs placebo (crossover design)
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Metformin
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2005
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Total final enrolment28
Key inclusion criteriaChildren and adolescents age 9-18 with obesity and insulin resistance, pre-type 2 diabetes.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/2005
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • Australia

Study participating centre

Institute of Endocrinology and Diabetes
Westmead NSW
2145
Australia

Sponsor information

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

Locked Bag 4001
Westmead NSW
2145
Australia

ROR logo "ROR" https://ror.org/05k0s5494

Funders

Funder type

Charity

Diabetes Australia Research Trust

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2006 12/01/2021 Yes No

Editorial Notes

12/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.