Biological variation of insulin resistance on polycystic ovarian syndrome and effect of treatment
| ISRCTN | ISRCTN58369615 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58369615 |
| Secondary identifying numbers | 07/03/117 |
- Submission date
- 25/01/2007
- Registration date
- 28/02/2007
- Last edited
- 29/03/2012
- 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
Centre for Diabetes and Endocrinology
220-236 Anlaby Road
Hull
HU3 2RW
United Kingdom
Study information
| Study design | Prospective study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Biological factors of insulin resistance and cardiovascular risk factors in women with polycystic ovarian syndrome: modification with diet, metformin, pioglitazone and orlistat |
| Study objectives | To determine if insulin resistance variability and the associated cardiovascular risk factor variability is affected by weight loss aided by the use of diet, orlistat, or by the insulin sensitising agents metformin, pioglitazone or soy in patients with polycystic ovarian syndrome (PCOS). |
| Ethics approval(s) | Ethics approval received from Hull and East Riding Local Research Ethics Committee (ref: 07/03/117). |
| Health condition(s) or problem(s) studied | Polycystic ovarian syndrome |
| Intervention | Treatment with either metformin, orlistat or pioglitazone. Dietary advise was based on the recommendation by the "British Heart Foundation's Guide for Healthy Eating" and for the soy treatment arm, a sachet containing 132 mg of phytoestrogen consisting mainly of genistein and daidzein in 30 g of soy protein was given. After baseline blood assessments, patients were randomised to either: 1. Dietary advice only 2. Metformin (500mg three times daily) 3. Orlistat (120mg three times daily) 4. Pioglitazone (45mg once daily) 5. Soy phytoestrogen Duration of treatment was for 3 months after which they came back for phase two of the study where further blood sampling was carried out. |
| Intervention type | Other |
| Primary outcome measure | Reduction in insulin resistance |
| Secondary outcome measures | Reduction in hyperandrogenaemia |
| Overall study start date | 06/08/2004 |
| Completion date | 30/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target number of participants | 40 |
| Key inclusion criteria | The diagnosis of PCOS will be based on evidence of hyperandrogenemia (Free androgen index > 8, with a history of oligomenorrhea and hirsutism or acne. Non classical 21-hydroxylase deficiency, hyperprolactinemia, and androgen secreting tumors will be excluded by appropriate tests before the diagnosis of PCOS will be made. Transvaginal ultrasound will also be performed to confirm the diagnosis of PCOS |
| Key exclusion criteria | 1. No subjects will be taking any medication currently or for the preceding six months 2. No concurrent illness 3. Patients not wishing to allow disclosure to their GPs |
| Date of first enrolment | 06/08/2004 |
| Date of final enrolment | 30/09/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Centre for Diabetes and Endocrinology
Hull
HU3 2RW
United Kingdom
HU3 2RW
United Kingdom
Sponsor information
Hull and East Yorkshire Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
England
United Kingdom
"ROR" |
https://ror.org/01b11x021 |
|---|
Funders
Funder type
University/education
University of Hull (UK) - Diabetes endowment fund
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 | 01/02/2009 | Yes | No |
