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

ISRCTN	ISRCTN81902209
DOI	https://doi.org/10.1186/ISRCTN81902209
Protocol serial number	R0794
Sponsor	Hull and East Yorkshire Hospitals NHS Trust (UK)
Funder	Diabetes Endowment Fund, University of Hull (UK)

Submission date: 27/04/2009
Registration date: 13/05/2009
Last edited: 26/04/2019

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

HS Brocklehurst Building
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2RW
United Kingdom

Study information

Primary study design	Interventional
Study design	Interventional open parallel single-centre trial
Secondary study design	Randomised parallel trial
Study type	Participant information sheet
Scientific title	Are early and late cardiovascular risk markers in women with polycystic ovary syndrome (PCOS) increased with concomitant non-alcoholic steatohepatitis (NASH) and can this be modified with exenatide?: An interventional open parallel single-centre trial
Study acronym	PCOS NASH 2009
Study objectives	Early and late cardiovascular risk markers are exaggerated in women with both polycystic ovary syndrome (PCOS) and non-alcoholic steatohepatitis (NASH) compared to either condition alone, and these can be modified by therapy reflected in an improvement in endothelial dysfunction, fibrin clot structure and function and an improvement in inflammation histologically.
Ethics approval(s)	Leeds East Research Ethics Committee, 09/03/2009, ref: 09/H1306/9
Health condition(s) or problem(s) studied	Polycystic ovary syndrome, non-alcoholic steatohepatitis
Intervention	Twelve patients will be recruited for each of the three groups: 1) PCOS only, 2) NASH only and 3) PCOS with NASH (total n = 36). Exenatide 5 mcg subcutaneously (sc) twice a day (bd) for 1 month then exenatide 10 mcg sc bd for 3 months.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Exenatide
Primary outcome measure(s)	1. To show that the combination of PCOS and NASH significantly amplifies cardiovascular risk markers compared to either PCOS or NASH alone 2. To show that intervention with exenatide significantly improves insulin resistance (an adverse cardiovascular risk marker) All primary and secondary outcomes will be assessed in September 2010.
Key secondary outcome measure(s)	1. To show that intervention with exenatide significantly improves endothelial function (Early manifestation of cardiovascular disease) in subjects with PCOS and NASH 2. To determine if exenatide therapy significantly improves fibrin clot structure and function (Late manifestation of cardiovascular disease) in subjects with PCOS and NASH 3. To determine if exenatide is effective in reducing steatohepatitis by Fibroscan® and reduces the markers of liver fibrosis All primary and secondary outcomes will be assessed in September 2010.
Completion date	30/09/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	36
Total final enrolment	20
Key inclusion criteria	For PCOS: 1. Polycystic ovary syndrome (defined by the Rotterdam criteria as 2 out of 3 of: 1.1. Oligo/anovulation 1.2. Clinical or biochemical evidence of hirsuitism, and/or 1.3. Polycystic ovaries on ultrasound 2. Raised alanine aminotransferase (ALT) 3. Female, age 16-45 years For NASH: 1. Patients with confirmed NASH 2. Female 3. Age 16-45 years
Key exclusion criteria	1. Ketoacidosis 2. Severe gastrointestinal disease 3. Type 2 diabetes 4. Hypothyroidism 5. Subjects taking regular prescribed medication 6. Not using a reliable method on contraception (eg barrier/oral contraceptive pill) 7. Patients not allowing disclosure to their GP's 8. History of pancreatitis 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 (e.g., ALT >90 u/mL) 12. Acute conditions with the potential to alter renal function such as: 12.1. Dehydration 12.2. Severe infection 12.3. Shock 12.4. Intravascular administration of iodinated contrast
Date of first enrolment	01/05/2009
Date of final enrolment	30/09/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

HS Brocklehurst Building

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	02/04/2019	26/04/2019	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

26/04/2019: Publication reference and total final enrolment number added.
12/07/2016: No publications found, verifying study status with principal investigator.