Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/04/2009
Date assigned
13/05/2009
Last edited
12/07/2016
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

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

R0794

Study information

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

Acronym

PCOS NASH 2009

Study hypothesis

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

Leeds East Research Ethics Committee, 09/03/2009, ref: 09/H1306/9

Study design

Interventional open parallel single-centre trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

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 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 names

Exenatide

Primary outcome measures

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.

Secondary outcome measures

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 FibroscanĀ® and reduces the markers of liver fibrosis

All primary and secondary outcomes will be assessed in September 2010.

Overall trial start date

01/05/2009

Overall trial end date

30/09/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

36

Participant 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

Recruitment start date

01/05/2009

Recruitment end date

30/09/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

HS Brocklehurst Building
Hull
HU3 2RW
United Kingdom

Sponsor information

Organisation

Hull and East Yorkshire Hospitals NHS Trust (UK)

Sponsor details

Daisy Building
Castle Hill Hospital
Cottingham
HU16 5JQ
United Kingdom

Sponsor type

Government

Website

http://www.hey.nhs.uk

Funders

Funder type

University/education

Funder name

Diabetes Endowment Fund, University of Hull (UK)

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

Publication citations

Additional files

Editorial Notes

12/07/2016: No publications found, verifying study status with principal investigator.