Know Cancer

or
forgot password

To Determine if the Cardiovascular Risk Indices Including Postprandial Hypertriglyceridaemia Are Modified Favourably by Nicotinic Acid (Niacin) in Patients With Polycystic Ovary Syndrome ( PCOS)


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

Thank you

Trial Information

To Determine if the Cardiovascular Risk Indices Including Postprandial Hypertriglyceridaemia Are Modified Favourably by Nicotinic Acid (Niacin) in Patients With Polycystic Ovary Syndrome ( PCOS)


Polycystic ovary syndrome is a common hormone problem in young women and, as a result of it,
they can experience irregular periods, reduced fertility, acne and increased body hair.
Frequently, increased weight is a feature. Research suggests that they could have a higher
risk of diabetes, high cholesterol and cardiovascular disease such as high blood pressure,
angina, heart attack and stroke.

The fat from the diet is transported from the stomach into the blood and then taken up by
the liver, muscles and fat tissues to store or use as an energy source. Delayed removal of
fat from the circulation resulting rise of fat after a meal has been known to happen in
PCOS. High fats after a meal are a strong risk factor for cardiovascular disease.

Niacin has been in clinical use to lower bad cholesterol and to increase good cholesterol
for many years. It has been proved to be effective in reducing risks of heart disease in
patients with diabetes. However the effect of niacin on reducing cardiovascular risks and
reducing fat level after a meal in PCOS has not been studied and this is why we plan to do
this research.


Inclusion Criteria:



- Females aged between 18 - 50 years

- Has polycystic ovary syndrome diagnosed according to Rotterdam consensus statement

Exclusion Criteria:

- Pregnancy/trying to conceive/breast feeding

- History of cardiovascular, renal, hepatic and active thyroid disease

- History of gout

- History of alcohol abuse

- History of diabetes

- History of allergy to nicotinic acid/laropiprant or food

- History of bleeding disorders/active peptic ulcers

- Patient on antihypertensive medications

- Patient on anticoagulants

- Patient on any hormonal replacement or oral contraceptive pills or cholesterol
lowering agents

- History of smoking more than 15 pack year

- Unwilling for GP to be informed

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Reduction in postprandial triglyceride

Outcome Description:

Postprandial triglyceride will be measured using meal test.

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Stephen L Atkin, FRCP, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Hull

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

R0920 PCOS & Niacin

NCT ID:

NCT01118598

Start Date:

June 2010

Completion Date:

May 2012

Related Keywords:

  • Polycystic Ovary Syndrome
  • PCOS
  • Polycystic Ovary Syndrome

Name

Location