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A Clinical Trial to Measure the Effect of DHA-enriched Fish Oils on Blood Pressure, Heart Rate Variability and Liver Fat Content in the Polycystic Ovary Syndrome


Phase 4
18 Years
50 Years
Not Enrolling
Female
Polycystic Ovary Syndrome

Thank you

Trial Information

A Clinical Trial to Measure the Effect of DHA-enriched Fish Oils on Blood Pressure, Heart Rate Variability and Liver Fat Content in the Polycystic Ovary Syndrome


The prevalence of abnormalities of blood pressure (ABP), variability of heart rate (HRV) and
liver fat content is increased in women with the polycystic ovary syndrome (PCOS). We
hypothesise that fish oils will have a beneficial effect on these endpoints and other
cardiometabolic parameters such as cholesterol and liver function in women with PCOS. This
crossover study of 40 obese women with PCOS will therefore examine the effects of fish oils
on the above parameters compared with placebo (olive oil). Subjects with PCOS who have
participated in previous studies with this research group will be approached for
recruitment, as will eligible subjects within the endocrine clinics of the chief and
co-investigators.


Inclusion Criteria:



- Overweight/obese women with PCOS as per 1990 NIH criteria (see below)

- Non-smokers

- Age>18 years, premenopausal

- Acceptable to have/be on treatment for type 2 diabetes mellitus and/or dyslipidaemia

- Acceptable to be taking the oral contraceptive pill

Exclusion Criteria:

- Uncontrolled hypertension (BP>160/100mmHg)

- Known co-morbidities including liver or renal disease

- Already taking fish oil supplements

- Other intercurrent illness (major surgery, CV event)

- Smokers

- Alcohol intake >20g/day

- Pregnancy

- Any metallic implant (contraindication for MRI).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

24 hour ambulatory systolic blood pressure

Outcome Time Frame:

week 8 and week 24

Safety Issue:

No

Principal Investigator

Andrea J Cussons, MBBS

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Western Australia

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

EC 2008/049

NCT ID:

NCT00620529

Start Date:

February 2008

Completion Date:

February 2009

Related Keywords:

  • Polycystic Ovary Syndrome
  • polycystic ovary syndrome
  • cardiovascular risk
  • metabolism
  • blood pressure
  • liver fat
  • heart rate variability
  • Polycystic Ovary Syndrome

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