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Assessment of Cardiovascular Risk in PCOS-a Cross Sectional Study of Women With PCOS Compared With Controls Matched for Age, Body Mass Index and, or Insulin Resistance


N/A
18 Years
40 Years
Not Enrolling
Female
Polycystic Ovary Syndrome

Thank you

Trial Information

Assessment of Cardiovascular Risk in PCOS-a Cross Sectional Study of Women With PCOS Compared With Controls Matched for Age, Body Mass Index and, or Insulin Resistance


Inclusion Criteria:



- Had a positive diagnosis of PCOS as defined according to the NIH criteria as chronic
oligomenorrhoea (< 9 menstrual cycles per year) and clinical and/or biochemical
evidence of hyperandrogenism, in the absence of other disorders causing the same
phenotype. Clinical criteria included hirsutism with a Ferriman-Galwey score greater
than 9, acne or male pattern alopecia; biochemical criteria included
total-testosterone, androstenedione or dehydroepiandrosterone sulphate (DHEAS)
greater than the laboratory reference range.

- Were between the ages of 18 and 40

Exclusion Criteria:

- Were under 18 years or greater than 40 years old,

- Were non-Caucasian

- Were pregnant, lactating or trying to conceive

- Had a body mass index (BMI) <18kg/m2 or >50kg/m2

- Had a recent illness or any chronic illness likely to influence results

- Were taking hormonal contraception

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Cross-Sectional

Outcome Measure:

Assessment of Insulin resistance in women with PCOS compared with BMI and age matched controls

Outcome Description:

Subjects underwent a standard 75g oral glucose tolerance test (OGTT) and blood were taken fasting and at 2 hours. Surrogate markers of insulin resistance (HOMA) and insulin sensitivity (Avignon index of Insulin Sensitivity; QUICKI) were calculated

Outcome Time Frame:

Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion

Safety Issue:

No

Principal Investigator

James Gibney, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Adelaide and Meath Hospital

Authority:

Ireland: Research Ethics Committee

Study ID:

DDC-UCD-CS

NCT ID:

NCT01195168

Start Date:

November 2006

Completion Date:

July 2008

Related Keywords:

  • Polycystic Ovary Syndrome
  • PCOS
  • Polycystic Ovary Syndrome

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