Condition category
Nutritional, Metabolic, Endocrine
Date applied
25/01/2007
Date assigned
28/02/2007
Last edited
03/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stephen Atkin

ORCID ID

Contact details

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

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

Sponsor information

Organisation

Hull and East Yorkshire Hospitals NHS Trust (UK)

Sponsor details

Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
United Kingdom

Sponsor type

Government

Website

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

  1. 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.

Additional files

Editorial Notes