Condition category
Nutritional, Metabolic, Endocrine
Date applied
25/04/2008
Date assigned
15/05/2008
Last edited
05/04/2012
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 Patrick Bell

ORCID ID

Contact details

East Wing Office
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
+44 28 9063 3423
patrick.bell@belfasttrust.hscni.net

Additional identifiers

EudraCT number

2007-004935-44

ClinicalTrials.gov number

Protocol/serial number

RGHTCUR125

Study information

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

Acronym

Study hypothesis

The peroxisome proliferator-activated receptor alpha agonist fenofibrate may increase insulin sensitivity compared to atorvastatin in type 2 diabetes mellitus.

Ethics approval

Local Research and Ethics Committee of the Queen's University of Belfast. Date of approval: 29/10/2003 (ref: 175/03)

Study design

Randomised, double-blind, prospective, two-period cross-over trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Condition

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Previous lipid-lowering therapy was withdrawn for 4 weeks prior to assessment for entry eligibility criteria.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

Phase

Not Specified

Drug names

Fenofibrate, atorvastatin

Primary outcome measures

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 trial start date

01/06/2004

Overall trial end date

25/01/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

12

Participant 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)

Recruitment start date

01/06/2004

Recruitment end date

25/01/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

East Wing Office
Belfast
BT12 6BA
United Kingdom

Sponsor information

Organisation

Belfast Health and Social Care Trust (UK)

Sponsor details

The Royal Research Office
Education & Research Centre
The Royal Hospitals
Belfast Trust and Social Care Trust
Grosvenor Road
Belfast
BT12 6BJ
United Kingdom
+44 28 9063 2224
frances.burns@belfasttrust.hscni.net

Sponsor type

Government

Website

http://www.belfasttrust.hscni.net

Funders

Funder type

Government

Funder name

Research Fellowship Award from the Research and Development Office of the Northern Ireland Department of Health and Social Services (ref: EAT/2197/02)

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

1. European Association for the Study of Diabetes, 2007 Black RN, Ennis CN, Young IS, Hunter SJ, Atkinson AB, Bell PM. The PPARa agonist fenofibrate does not improve insulin sensitivity in type 2 diabetes in man; results of a randomised trial. Diabetologia 2007; 50(suppl 1): S320.
2. Diabtes UK, 2007 Black RNA, Ennis CN, Young IS, Hunter SJ, Atkinson AB, Bell PM. The effect of PPAR alpha agonist fenofibrate on insulin sensitivity in man: a randomised controlled trial. Diabetic Medicine 2007; 24(suppl 1): 44.

Publication citations

Additional files

Editorial Notes