Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims:
Polycystic ovary syndrome (PCOS) is a common condition in women of reproductive age. PCOS is associated with cardiovascular risk through increased insulin resistance. This in turn may lead to increased risk of non-alcoholic fatty liver disease (NAFLD). Both conditions are made worse by obesity. Liraglutide has been shown to reduce weight, but it is unknown if liraglutide improves cardiovascular risk factors in women with PCOS with or without NALFD.

Who can participate?
Two groups of women: 20 with PCOS; 20 age and weight matched normal control subjects.

What does the study involve?
Participants are treated with liraglutide 1.8mg once a day for 6 months followed by metformin 500mg three times a day for 3 months. Study participants will be seen every 3 months. At each visit blood will be taken to measure for insulin resistance, and for clotting and inflammations markers. Artery wall thickness will be measured at baseline and after 6 months treatment with liraglutide.

What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part but the study will improve our understanding of PCOS and the treatment of people with PCOS and fatty liver disease. Most common side effects with metformin and liraglutide use are nausea and diarrhoea. These side effects usually disappear after a few days. There might be some discomfort in blood testing and endothelial function measurement.

Where is the study run from?
Diabetes Research Centre at Hull Royal Infirmary (UK).

When is the study starting and how long is it expected to run for?
May 2010 to December 2012.

Who is funding the study?
Diabetes Research fund, University of Hull (UK).

Who is the main contact?
Professor Stephen L Atkin

Trial website

Contact information



Primary contact

Prof Stephen Atkin


Contact details

Head of Diabetes
Endocrinology and Metabolism
University of Hull
Brocklehurst building
Hull Royal Infirmary
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number

Protocol version 7

Study information

Scientific title

Are early and late cardiovascular risk markers in women with polycystic ovary syndrome increased with concomitant non-alcoholic steatohepatitis and can this be modified with liraglutide?


Study hypothesis

Intervention with liraglutide significantly improves insulin resistance, carotid intima-media wall thickness (cIMT), platelet and endothelial function in women with PCOS and Non-alcoholic fatty liver disease (NAFLD).

Ethics approval

Leeds East Research Ethics Committee, 08/02/2010

Study design

Open parallel single-centre trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Polycystic Ovary Syndrome


Women with PCOS were diagnosed according to the Rotterdam criteria. Other endocrine disorders with similar presentation were excluded. Normal control women underwent similar tests to rule out any unknown medical problem.

Participants (PCOS and nomal controls) are treated with liraglutide 1.8mg once a day for 6 months followed by metformin 500mg three times a day for 3 months. Study participants will be seen every 3 months during the study.

Intervention type



Not Applicable

Drug names

Liraglutide, metformin

Primary outcome measure

Improvement in cIMT and platelet function measured at baseline and after 6 months treatment with Liraglutide

Secondary outcome measures

1. Improvement in endothelial function will be measured using EndoPat 2000 at baseline, 3, 6 and 9 months of treatment
2. Liver fibrosis markers were measured at baseline, 3, 6 and 9months of treatment
3. Depression [Centre for Epidemiologic Studies Depression Scale (CES-D)] at baseline and after 6 months of treatment with liraglutide
4. Quality of life will be measured using WHO QoL questionaire at baseline and after 6 months of treatment with liraglutide

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Polycystic ovary syndrome (defined by the Rotterdam criteria) as 2 out of 3 of:
1. Oligo / anovulation
2. Clinical or biochemical evidence of hirsuitism, and/or
3. Polycystic ovaries on ultrasound and the exclusion of other disorders
4. Age 18-45 years

For normal controls:
1. Female, aged 18 - 45
2. Body madd index (BMI) 30 - 45
3. No current medical problems

Participant type


Age group




Target number of participants

40 participants

Participant exclusion criteria

1. Ketoacidosis
2. Severe gastrointestinal disease
3. Hypothyroidism
4. Subjects taking regular medications associated with high risk of hepatotoxicity like isoniazid and methotrexate
5. Not using a reliable method of contraception
6. Patients not allowing disclosure to their GP's
7. History of pancreatitis
8. Heart Failure
9. Chronic renal failure (creatinine clearance less than 60 ml/min or plasma creatinine >150 umol/L)
10. Pregnancy or breastfeeding women
11. Liver function tests >300% reference range normal (eg ALT>90 u/mL)
12. Type 2 diabetes mellitus
13. Acute conditions with the potential to alter renal function such as: dehydration / severe infection / shock / intravascular administration of iodinated contrast

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Hull
United Kingdom

Sponsor information


Hull and East Yorkshire Hospitals NHS Trust (UK)

Sponsor details

c/o James Illingworth
Research and Development
Daisy Building
Castle Hill Hospital
Castle Road
HU16 5JQ
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

University of Hull - Diabetes Research Fund (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

2015 results in:

Publication citations

Additional files

Editorial Notes