Biological variation of insulin resistance, testosterone and cardiovascular risk factors in women with polycystic ovary syndrome: modification with rimonabant compared to metformin
| ISRCTN | ISRCTN75758249 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75758249 |
| Secondary identifying numbers | R0391 |
- Submission date
- 23/10/2007
- Registration date
- 31/10/2007
- Last edited
- 18/01/2012
- 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
Prof Stephen Atkin
Scientific
Scientific
Michael White Diabetes Centre
Hull Royal Infirmary
220-236 Analby Road
Hull
HU3 2JZ
United Kingdom
| Phone | +44 (0)1482 6765 |
|---|---|
| s.l.atkin@hull.ac.uk |
Study information
| Study design | Randomised, open-label, parallel study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 1. To show that rimonabant treatment is superior to metformin in reducing mean insulin resistance, high androgen levels and cardiovascular risk indices in women with PolyCystic Ovarian Syndrome (PCOS) 2. To show that rimonabant treatment is superior to metformin in reducing the fluctuations in biological variation of insulin resistance in PCOS |
| Ethics approval(s) | Ethics approval received from Hull and East Riding Local Research Ethics Committee on the 19th December 2006 (ref: 06/Q1104/115). |
| Health condition(s) or problem(s) studied | PolyCystic Ovary Syndrome (PCOS) |
| Intervention | Rimonabant 20 mg (oral) daily or metformin 500 mg (oral) three times a day (tds) for 3 months. |
| Intervention type | Other |
| Primary outcome measure | The following will be assessed at 3 months: 1. The HOMeostasis model Assessment of Insulin Resistance (HOMA-IR) 2. Testosterone |
| Secondary outcome measures | The following will be assessed at 3 months: 1. Waist cirumference 2. Free androgen index |
| Overall study start date | 01/09/2006 |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target number of participants | 20 |
| Key inclusion criteria | 1. Polycystic ovarian syndrome 2. Body Mass Index (BMI) greater than 30 kg/m^2 |
| Key exclusion criteria | 1. Patient should not be on any drugs 2. Unwilling for General Practitioner (GP) to be informed 3. Diabetic patients 4. Uncompensated hypothyroidism 5. Patients not on barrier contraception 6. History of psychiatric disorder or severe depression 7. Chronic renal failure |
| Date of first enrolment | 01/09/2006 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Michael White Diabetes Centre
Hull
HU3 2JZ
United Kingdom
HU3 2JZ
United Kingdom
Sponsor information
Hull and East Yorkshire Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Mrs Nina Dunham
R&D admin portacabin
Castle Hill Hospital
Castle Road
Cottingham, East Yorkshire
Hull
HU16 5JQ
England
United Kingdom
| Website | http://www.hey.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/01b11x021 |
Funders
Funder type
University/education
University of Hull (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 01/01/2009 | Yes | No |
