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

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

Study information

Study designProspective study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleBiological factors of insulin resistance and cardiovascular risk factors in women with polycystic ovarian syndrome: modification with diet, metformin, pioglitazone and orlistat
Study objectivesTo 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) studiedPolycystic ovarian syndrome
InterventionTreatment 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 typeOther
Primary outcome measureReduction in insulin resistance
Secondary outcome measuresReduction in hyperandrogenaemia
Overall study start date06/08/2004
Completion date30/09/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexFemale
Target number of participants40
Key inclusion criteriaThe 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 criteria1. 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 enrolment06/08/2004
Date of final enrolment30/09/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Centre for Diabetes and Endocrinology
Hull
HU3 2RW
United Kingdom

Sponsor information

Hull and East Yorkshire Hospitals NHS Trust (UK)
Hospital/treatment centre

Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
England
United Kingdom

ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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