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11 February 2012
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| [ Print-friendly version ] |
| To determine if cardiovascular risk indices including postprandial hypertriglyceridaemia are modified favourably by nicotinic acid (niacin) in patients with polycystic ovary syndrome (PCOS) |
| ISRCTN | ISRCTN37787683 |
| ClinicalTrials.gov identifier | |
| Public title | To determine if cardiovascular risk indices including postprandial hypertriglyceridaemia are modified favourably by nicotinic acid (niacin) in patients with polycystic ovary syndrome (PCOS) |
| Scientific title | To determine if cardiovascular risk indices including postprandial hypertriglyceridaemia are modified favourably by nicotinic acid (niacin) in patients with polycystic ovary syndrome (PCOS): a randomised double blind placebo controlled parallel study |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis | Niacin will improve postprandial hyperlipidaemia and cardiovascular risks indices via its lipid lowering as well as via pleiotrophic effects in patients with polycystic ovary syndrome (PCOS). |
| Lay summary | |
| Ethics approval | Leeds (East) Research Ethics Committee approved on the 21st January 2010 (ref: 09/H1306/103) |
| Study design |
Single centre randomised double blind placebo controlled parallel trial
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| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Polycystic ovary syndrome |
| Participants - inclusion criteria |
1. Females aged between 18 - 50 years
2. Has polycystic ovary syndrome diagnosed according to Rotterdam consensus statement (to meet two out three criteria after exclusion of other endocrine disorders): 2.1. Patient has oligomenorrhoea (less than 9 cycles per year)/anovulation 2.2. Patient has evidence of clinical/biochemical hyperandrogenism 2.3. Patient has polycystic ovaries on trans-vaginal ultrasound |
| Participants - exclusion criteria |
1. Pregnancy/trying to conceive/breast feeding
2. History of cardiovascular, renal, hepatic and active thyroid disease 3. History of gout 4. History of alcohol abuse 5. History of diabetes 6. History of allergy to nicotinic acid/laropiprant or food 7. History of bleeding disorders/active peptic ulcers 8. Patient on antihypertensive medications 9. Patient on anticoagulants 10. Patient on any hormonal replacement or oral contraceptive pills or cholesterol lowering agents 11. History of smoking more than 15 pack year 12. Unwilling for GP to be informed |
| Anticipated start date | 01/04/2010 |
| Anticipated end date | 01/10/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 36 |
| Interventions |
Patients will be allocated as 1:1 ratio to the intervention group and the placebo group. For the first 4 weeks, participants will take orally either one tablet of nicotinic acid 1000 mg/laropiprant 20 mg (Tredaptive®) or one tablet of placebo per day. If patient tolerates it, the dose will be increased to either two tablets of nicotinic acid 1000 mg/laropiprant 20 mg (Tredaptive®) or two tablets of placebo per day from week 5 to week 12.
Total duration of treatment is 12 weeks and total duration of follow-up is up to 2 weeks after the end of intervention. |
| Primary outcome measure(s) | To determine if the dyslipidaemic cardiovascular risk indices including postprandial hypertriglyceridaemia are reversed favourably by nicotinic acid (niacin) therapy. Blood tests will be done at baseline, at week 5 and at week 9 and at the completion of the intervention for both groups. |
| Secondary outcome measure(s) |
1. To determine the effect of nicotinic acid on insulin resistance and other markers of cardiovascular risk such as high sensitivity c-reative protein (hsCRP)
2. To determine the effect of nicotinic acid on endothelial function Blood tests will be done at baseline, at week 5 and at week 9 and at the completion of the intervention for both groups. Endothelial function test will be done at baseline and at the end of the study. |
| Sources of funding |
1. Hull and East Yorkshire Hospital NHS Trust (UK) - Research and Development Department
2. Merck, Sharp & Dohme Corp. (UK) - supplies study medicine (Tredaptive® and placebo) |
| Trial website | |
| Publications | |
| Contact name | Prof Stephen Atkin |
| Address |
Department of Diabetes, Endocrinology and Metabolism
Hull York Medical School Michael White Diabetes Centre Hull Royal Infirmary |
| City/town | Hull |
| Zip/Postcode | HU3 2RW |
| Country | United Kingdom |
| Tel | +44 (0)1482 675 365 |
| Fax | +44 (0)1482 675 370 |
| stephen.atkin@hyms.ac.uk | |
| Sponsor | Hull and East Yorkshire Hospital NHS Trust (UK) |
| Address |
c/o James Illingworth
R & D Manager 2nd Floor, Daisy Building Castle Hill Hospital, Cottingham |
| City/town | Hull |
| Zip/Postcode | HU16 5JQ |
| Country | United Kingdom |
| Sponsor website: | http://www.hey.nhs.uk/HomeContentWithNews.aspx?PageID=1&SectionID=1 |
| Date applied | 05/02/2010 |
| Last edited | 10/03/2010 |
| Date ISRCTN assigned | 10/03/2010 |
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