Condition category
Nutritional, Metabolic, Endocrine
Date applied
25/01/2007
Date assigned
28/02/2007
Last edited
29/03/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stephen Atkin

ORCID ID

Contact details

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

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

Sponsor information

Organisation

Hull and East Yorkshire Hospitals NHS Trust (UK)

Sponsor details

Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
United Kingdom

Sponsor type

Government

Website

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

  1. 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.

Additional files

Editorial Notes