Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
02/98/249
Study information
Scientific title
Acronym
Biological variation in PCOS
Study hypothesis
Women with polycystic ovarian syndrome has a higher and more variable insulin resistance than controls
Ethics approval
Hull and East Riding Local Research Ethics Committee. LREC number : 02/98/249
Study design
Comparison study
Primary study design
Observational
Secondary study design
Cross-section survey
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Condition
Polycystic ovarian syndrome
Intervention
Primary outcome was the comparison of insulin resistance in polycystic ovarian syndrome and controls. Venous blood was taken for measurement of insulin and glucose levels, and insulin resistance was calculated by HOMA-IR (insulin x glucose /22.5).
Secondary outcome was the biological variation of insulin resistance in polycystic ovarian syndrome and controls. Insulin resistance was calculated by HOMA-IR as above, and calculation of biological variation was done on 10 consecutive HOMA-IR taken at 4-day intervals.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Comparison of Insulin resistance in polycystic ovarian syndrome and controls
Secondary outcome measures
Comparison of biological variation of polycystic ovarian syndrome with controls
Overall trial start date
28/02/2002
Overall trial end date
31/12/2004
Reason abandoned
Eligibility
Participant inclusion criteria
The diagnosis of PCOS will be based on evidence of hyperandrogenemia (Free androgen index > 8, with a history of oligomenorrhea and hirsutism or acne. Non classical 21-hydroxylase deficiency, hyperprolactinemia, and androgen secreting tumors will be excluded by appropriate tests before the diagnosis of PCOS will be made. Transvaginal ultrasound will also be performed to confirm the diagnosis of PCOS
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
40
Participant exclusion criteria
1. No subjects will be taking any medication currently or for the preceding six months
2. No concurrent illness
3. Patients not wishing to allow disclosure to their GPs
Recruitment start date
28/02/2002
Recruitment end date
31/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre for Diabetes and Endocrinology
Hull
HU3 2RW
United Kingdom
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
2002 results in http://www.ncbi.nlm.nih.gov/pubmed/11932282
Publication citations
-
Results
Jayagopal V, Kilpatrick ES, Holding S, Jennings PE, Atkin SL, The biological variation of insulin resistance in polycystic ovarian syndrome., J. Clin. Endocrinol. Metab., 2002, 87, 4, 1560-1562, doi: 10.1210/jcem.87.4.8404.