Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/07/2005
Date assigned
13/09/2005
Last edited
25/04/2014
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

Dr Rossi Naoumova

ORCID ID

Contact details

MRC Clinical Sciences Centre
Hammersmith Hospital
Du Cane Road
London
W12 0NN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

We hypothesise that patients with familial combined hyperlipidaemia will have increased skeletal muscle and liver triglyceride content as well as visceral obesity. Treatment with pioglitazone will improve these abnormalities and the lipid profile as a result of increased insulin sensitivity through its action on the PPAR gamma-receptor.

Ethics approval

Research Ethics Committee approval No. 2002/6480

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Familial Combined Hyperlipidaemia

Intervention

Treatment with pioglitazone versus placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Pioglitazone

Primary outcome measures

Skeletal muscle and liver triglyceride content, using 1H – Magnetic Resonance Spectroscopy (1H-MRS) and total body fat map: visceral, non-visceral and subcutaneous, using Magnetic Resonance Imaging (MRI)

Secondary outcome measures

Parameters of lipid and carbohydrate metabolism: Total cholesterol, triglyceride, HDL cholesterol, LDL cholesterol, total to HDL cholesterol ratio, Non-Esterified Fatty Acids (NEFA), Lipoprotein a (Lp(a)), apolipoprotein A-I, apolipoprotein B, glucose, insulin, leptin

Overall trial start date

18/12/2002

Overall trial end date

30/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age between 18-75 years
2. Familial combined hyperlipidaemia (CHL) that fits the above criteria
3. Inadequately controlled with conventional lipid lowering medication, with at least one of the following: total cholesterol >5.0 mmol/l; triglyceride >1.7 mmol/l; HDL-cholesterol <1.0 mmol/l; total cholesterol:HDL cholesterol ratio >5.0
4. Willing and able to comply with the conditions and requirements of the study
5. Signed and dated an informed consent form and be able to comply with the study procedures

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

26

Participant exclusion criteria

1. Hyperlipidaemia at diagnosis, secondary to obesity, diabetes mellitus, hypothyroidism, liver or kidney disease
2. Taking medication affecting serum lipids or excessive alcohol intake
3. Other forms of genetic hyperlipidaemia (familial hypercholesterolaemia)
4. Pregnancy
5. MI ('heart attack'), stroke or transient ischaemic attack ('mini stroke') in the previous 6 months
6. Malignant disease (cancer) in the previous 5 years (except basal cell carcinoma)
7. Type 1 or type 2 diabetes mellitus
8. NYHA class II, III or IV (mild, moderate or severe Heart Failure)
9. Alcohol or drug abuse
10. Significant renal (kidney) impairment (creatinine >135 µmol/l)
11. Abnormal liver tests (alanine aminotransferase [ALT] >2.5 times the upper limit of the reference range)
12.Had any alteration in their lipid lowering medication (dose or drug) in the previous 2 months
13. Had treatment with corticosteroids ('cortisol') in the previous 4 weeks (use of topical or inhaled corticosteroids is allowed)
14. Taken another investigational study drug or product within the previous 3 months
15. Donated or received blood or blood products within the previous 3 months
16. Females who are any of the following: Planning pregnancy during the study or breast feeding, or child bearing potential and not planning to use a reliable method of contraception throughout the study (e.g. oral contraception)
17. Any other condition or circumstance that, in the opinion of the investigator, may compromise the patient's ability to comply with the study protocol
18. An inability to tolerate MRI/MRS scanning (claustrophobia)
19. Standard contraindications for MRI/MRS scanning (e.g. cardiac pacemaker, mechanical heart valve, history of foreign body in the eye, IUCD, haemostatic clips, metal prosthesis, orthopaedic plates, occupation as metal worker, welder etc.)

Recruitment start date

18/12/2002

Recruitment end date

30/06/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Sciences Centre
London
W12 0NN
United Kingdom

Sponsor information

Organisation

Medical Research Council (UK)

Sponsor details

Clinical Sciences Centre
Hammersmith HospitalMedical
Du Cane Road
London
W12 0NN
United Kingdom

Sponsor type

Research council

Website

http:\\www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council and J Coller Foundation (UK)

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

2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/17482623

Publication citations

  1. Results

    Thomas EL, Potter E, Tosi I, Fitzpatrick J, Hamilton G, Amber V, Hughes R, North C, Holvoet P, Seed M, Betteridge DJ, Bell JD, Naoumova RP, Pioglitazone added to conventional lipid-lowering treatment in familial combined hyperlipidaemia improves parameters of metabolic control: relation to liver, muscle and regional body fat content., Atherosclerosis, 2007, 195, 1, e181-90, doi: 10.1016/j.atherosclerosis.2007.03.043.

Additional files

Editorial Notes