Insulin resistance and obesity in adolescents - metabolic characterisation and effects of therapeutic intervention with metformin
| ISRCTN | ISRCTN43267711 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43267711 |
| Protocol serial number | 2001/054 |
| Sponsor | The Children's Hospital, Westmead - Research and Development Office (Australia) |
| Funder | Diabetes Australia Research Trust |
- 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
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 |
|---|---|
| geoffa@chw.edu.au |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Insulin resistance and obesity in adolescents - metabolic characterisation and effects of therapeutic intervention with metformin |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Insulin resistance and obesity |
| Intervention | Metformin vs placebo (crossover design) |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Metformin |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Total final enrolment | 28 |
| Key inclusion criteria | Children and adolescents age 9-18 with obesity and insulin resistance, pre-type 2 diabetes. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Australia
Study participating centre
Institute of Endocrinology and Diabetes
Westmead NSW
2145
Australia
2145
Australia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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.
