Biological Variation of insulin resistance in normal ovulating women and PolyCystic Ovarian Syndrome

ISRCTN	ISRCTN65353256
DOI	https://doi.org/10.1186/ISRCTN65353256
Protocol serial number	02/98/249
Sponsor	Hull and East Yorkshire Hospitals NHS Trust (UK)
Funder	Diabetes endowment Fund, University of Hull (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Stephen Atkin
Scientific

Centre for Diabetes and Endocrinology
220-236 Anlaby Road
Hull
HU3 2RW
United Kingdom

Primary study design	Observational
Study design	Comparison study
Secondary study design	Cross-section survey
Scientific title
Study acronym	Biological variation in PCOS
Study objectives	Women with polycystic ovarian syndrome has a higher and more variable insulin resistance than controls
Ethics approval(s)	Hull and East Riding Local Research Ethics Committee. LREC number : 02/98/249
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Comparison of Insulin resistance in polycystic ovarian syndrome and controls
Key secondary outcome measure(s)	Comparison of biological variation of polycystic ovarian syndrome with controls
Completion date	31/12/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target sample size at registration	40
Key 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
Key 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
Date of first enrolment	28/02/2002
Date of final enrolment	31/12/2004

Centre for Diabetes and Endocrinology

Hull
HU3 2RW
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2002		Yes	No