Condition category
Nutritional, Metabolic, Endocrine
Date applied
05/02/2010
Date assigned
10/03/2010
Last edited
05/08/2014
Prospective/Retrospective
Prospectively 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

Department of Diabetes
Endocrinology and Metabolism
Hull York Medical School
Michael White Diabetes Centre
Hull Royal Infirmary
Hull
HU3 2RW
United Kingdom
+44 (0)1482 675 365
stephen.atkin@hyms.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

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).

Ethics approval

Leeds (East) Research Ethics Committee, 21/01/2010, ref: 09/H1306/103

Study design

Single-centre randomised double-blind placebo-controlled parallel trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Polycystic ovary syndrome

Intervention

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.

Intervention type

Drug

Phase

Phase IV

Drug names

Niacin, laropiprant (Tredaptive®)

Primary outcome measures

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 measures

1. To determine the effect of nicotinic acid on insulin resistance and other markers of cardiovascular risk such as high sensitivity c-reactive 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.

Overall trial start date

01/04/2010

Overall trial end date

01/10/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Females aged between 18 - 50 years
2. Has polycystic ovary syndrome diagnosed according to Rotterdam consensus statement (to meet two out of three criteria after exclusion of other endocrine disorders):
2.1. Patient has oligomenorrhoea (less than nine cycles per year)/anovulation
2.2. Patient has evidence of clinical/biochemical hyperandrogenism
2.3. Patient has polycystic ovaries on trans-vaginal ultrasound

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

36

Participant exclusion criteria

1. Pregnancy/trying to conceive/breastfeeding
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

Recruitment start date

01/04/2010

Recruitment end date

01/10/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Diabetes, Endocrinology and Metabolism
Hull
HU3 2RW
United Kingdom

Sponsor information

Organisation

Hull and East Yorkshire Hospital NHS Trust (UK)

Sponsor details

c/o James Illingworth
R & D Manager
2nd Floor
Daisy Building
Castle Hill Hospital
Cottingham
Hull
HU16 5JQ
United Kingdom

Sponsor type

Government

Website

http://www.hey.nhs.uk/HomeContentWithNews.aspx?PageID=1&SectionID=1

Funders

Funder type

Government

Funder name

Hull and East Yorkshire Hospital NHS Trust (UK) - Research and Development Department

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Merck, Sharp & Dohme Corp. (UK) - supplies study medicine (Tredaptive® and placebo)

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24401089

Publication citations

  1. Results

    Aye MM, Kilpatrick ES, Afolabi P, Wootton SA, Rigby AS, Coady AM, Sandeman DD, Atkin SL, Postprandial effects of long-term niacin/laropiprant use on glucose and lipid metabolism and on cardiovascular risk in patients with polycystic ovary syndrome., Diabetes Obes Metab, 2014, 16, 6, 545-552, doi: 10.1111/dom.12255.

Additional files

Editorial Notes