Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
07/03/117
Study information
Scientific title
Biological factors of insulin resistance and cardiovascular risk factors in women with polycystic ovarian syndrome: modification with diet, metformin, pioglitazone and orlistat
Acronym
Study hypothesis
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
Ethics approval received from Hull and East Riding Local Research Ethics Committee (ref: 07/03/117).
Study design
Prospective study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Reduction in insulin resistance
Secondary outcome measures
Reduction in hyperandrogenaemia
Overall trial start date
06/08/2004
Overall trial end date
30/09/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
40
Participant 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
Recruitment start date
06/08/2004
Recruitment end date
30/09/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre for Diabetes and Endocrinology
Hull
HU3 2RW
United Kingdom
Funders
Funder type
University/education
Funder name
University of Hull (UK) - Diabetes endowment fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18547343
Publication citations
-
Results
Cho LW, Kilpatrick ES, Keevil BG, Coady AM, Atkin SL, Effect of metformin, orlistat and pioglitazone treatment on mean insulin resistance and its biological variability in polycystic ovary syndrome., Clin. Endocrinol. (Oxf), 2009, 70, 2, 233-237, doi: 10.1111/j.1365-2265.2008.03309.x.