Biological variation of insulin resistance on polycystic ovarian syndrome and effect of treatment

ISRCTN	ISRCTN58369615
DOI	https://doi.org/10.1186/ISRCTN58369615
Protocol serial number	07/03/117
Sponsor	Hull and East Yorkshire Hospitals NHS Trust (UK)
Funder	University of Hull (UK) - Diabetes endowment fund

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

Centre for Diabetes and Endocrinology
220-236 Anlaby Road
Hull
HU3 2RW
United Kingdom

Study information

Primary study design	Interventional
Study design	Prospective study
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Reduction in insulin resistance
Key secondary outcome measure(s)	Reduction in hyperandrogenaemia
Completion date	30/09/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target sample size at registration	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

United Kingdom
England

Study participating centre

Centre for Diabetes and Endocrinology

Hull
HU3 2RW
United Kingdom

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	01/02/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes