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

ISRCTN ISRCTN65353256
DOI https://doi.org/10.1186/ISRCTN65353256
Secondary identifying numbers 02/98/249
Submission date
25/01/2007
Registration date
28/02/2007
Last edited
03/05/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Stephen Atkin
Scientific

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

Study information

Study designComparison study
Primary study designObservational
Secondary study designCross-section survey
Study setting(s)Hospital
Study typeNot Specified
Scientific title
Study acronymBiological variation in PCOS
Study objectivesWomen 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) studiedPolycystic ovarian syndrome
InterventionPrimary 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 typeOther
Primary outcome measureComparison of Insulin resistance in polycystic ovarian syndrome and controls
Secondary outcome measuresComparison of biological variation of polycystic ovarian syndrome with controls
Overall study start date28/02/2002
Completion date31/12/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexFemale
Target number of participants40
Key inclusion criteriaThe 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 criteria1. 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 enrolment28/02/2002
Date of final enrolment31/12/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Centre for Diabetes and Endocrinology
Hull
HU3 2RW
United Kingdom

Sponsor information

Hull and East Yorkshire Hospitals NHS Trust (UK)
Hospital/treatment centre

Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
England
United Kingdom

ROR logo "ROR" https://ror.org/01b11x021

Funders

Funder type

University/education

Diabetes endowment Fund, University of Hull (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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