Biological Variation of insulin resistance in normal ovulating women and PolyCystic Ovarian Syndrome
ISRCTN | ISRCTN65353256 |
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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
Scientific
Centre for Diabetes and Endocrinology
220-236 Anlaby Road
Hull
HU3 2RW
United Kingdom
Study information
Study design | Comparison study |
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Primary study design | Observational |
Secondary study design | Cross-section survey |
Study setting(s) | Hospital |
Study type | Not Specified |
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 | Comparison of Insulin resistance in polycystic ovarian syndrome and controls |
Secondary outcome measures | Comparison of biological variation of polycystic ovarian syndrome with controls |
Overall study start date | 28/02/2002 |
Completion date | 31/12/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Female |
Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Centre for Diabetes and Endocrinology
Hull
HU3 2RW
United Kingdom
HU3 2RW
United Kingdom
Sponsor information
Hull and East Yorkshire Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
England
United Kingdom
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |