To see if fenofibrate has any advantage over atorvastatin in effects on insulin sensitivity in volunteers with type 2 diabetes
ISRCTN | ISRCTN70518596 |
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DOI | https://doi.org/10.1186/ISRCTN70518596 |
EudraCT/CTIS number | 2007-004935-44 |
Secondary identifying numbers | RGHTCUR125 |
- Submission date
- 25/04/2008
- Registration date
- 15/05/2008
- Last edited
- 12/04/2021
- 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 Patrick Bell
Scientific
Scientific
East Wing Office
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
Phone | +44 28 9063 3423 |
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patrick.bell@belfasttrust.hscni.net |
Study information
Study design | Randomised, double-blind, prospective, two-period cross-over trial. |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | The effect of the peroxisome proliferator-activated receptor alpha agonist fenofibrate on insulin sensitivity compared to atorvastatin in type 2 diabetes mellitus: A randomised, double-blind controlled trial |
Study objectives | The peroxisome proliferator-activated receptor alpha agonist fenofibrate may increase insulin sensitivity compared to atorvastatin in type 2 diabetes mellitus. |
Ethics approval(s) | Local Research and Ethics Committee of the Queen's University of Belfast. Date of approval: 29/10/2003 (ref: 175/03) |
Health condition(s) or problem(s) studied | Type 2 diabetes mellitus, insulin resistance |
Intervention | This is a randomised, cross-over trial. Treatment 1: Micronised fenofibrate (oral) 267 mg once daily Treatment 2: Atorvastatin (oral) 10 mg once daily Intervention schedule: Previous lipid-lowering therapy was withdrawn for 4 weeks prior to assessment for entry eligibility criteria. Subjects then commenced a 4-week placebo run-in after which baseline assessments were carried out. The participants were then randomised to either fenofibrate or atorvastatin in a double-blinded manner and continued for 12 weeks, after which end-point assessments were carried out. A 4-week placebo-controlled washout period followed, and then subjects proceeded to 12 weeks therapy with the alternative blinded therapy (atorvastatin or fenofibrate). End-points were again assessed after this treatment period. The full period of follow-up of each individual volunteer was 36 weeks, and is broken down as follows: 1. 4 week washout period from previous therapy 2. 4 week placebo run-in period 3. 12 week treatment period 1 4. 4 week placebo wash-out period 5. 12 week treatment period 2 |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Fenofibrate, atorvastatin |
Primary outcome measure | Glucose infusion rate required to maintain isoglycaemia in the last 30 minutes of a 2-hour insulin infusion at a rate of 2 mU/kg/minute. This was assessed within three days of the end of each treatment period. |
Secondary outcome measures | The following were assessed within three days of the end of each treatment period: 1. Isotopically-determined total body glucose disposal rate and suppression of endogenous glucose production in the last 30 minutes of a 2-hour insulin infusion at a rate of 2 mU/kg/minute 2. Serum total, low-density and high density cholesterol and fasting total triglyceride |
Overall study start date | 01/06/2004 |
Completion date | 25/01/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Not Specified |
Target number of participants | 12 |
Total final enrolment | 13 |
Key inclusion criteria | 1. Males and post-menopausal females 2. Aged 35-70 years old 3. Type 2 diabetes mellitus, clinically well 4. On diet or oral anti-diabetic therapy 5. Fasting total triglyceride <4.5 mmol/L |
Key exclusion criteria | 1. Age <35 or >70 years 2. Total fasting triglycerides pre-treatment or after withdrawal of previous therapy >= 4.5mmol/L 3. Total cholesterol >6.5 mmol/L 4. Excess alcohol consumption 5. Ischaemic heart, peripheral vascular or cerebrovascular disease 6. Hepatic disease 7. Epilepsy 8. Body mass index >35 kg/m^2 9. Pre-menopausal females 10. HbA1c >8% 11. Current insulin or thiazolidinedione therapy within 6 months 12. Significant renal impairment or overt proteinuria (serum creatinine >150 µmol/L, estimated glomerular filtration rate (eGFR) by the Modification of Diet in Renal Disease (MDRD) formula <50 mL/minute, urine spot albumin >200 mg/L, albumin-creatinine ratio >20 mg/mmol or 24-hour urine protein >300 mg) 13. Uncontrolled hypertension (>140/80 mmHg) |
Date of first enrolment | 01/06/2004 |
Date of final enrolment | 25/01/2006 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
East Wing Office
Belfast
BT12 6BA
United Kingdom
BT12 6BA
United Kingdom
Sponsor information
Belfast Health and Social Care Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
The Royal Research Office
Education & Research Centre
The Royal Hospitals
Belfast Trust and Social Care Trust
Grosvenor Road
Belfast
BT12 6BJ
Northern Ireland
United Kingdom
Phone | +44 28 9063 2224 |
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frances.burns@belfasttrust.hscni.net | |
Website | http://www.belfasttrust.hscni.net |
https://ror.org/02tdmfk69 |
Funders
Funder type
Government
Research Fellowship Award from the Research and Development Office of the Northern Ireland Department of Health and Social Services (ref: EAT/2197/02)
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? |
---|---|---|---|---|---|
Abstract results | p.44 | 20/02/2007 | No | No | |
Abstract results | 21/08/2007 | No | No | ||
Results article | 01/05/2014 | 12/04/2021 | Yes | No |
Editorial Notes
12/04/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.