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| [ ...Back to search results ] | [ Print-friendly version ] |
| A pilot study to investigate the effect of pioglitazone on muscle and liver triglyceride content and total body fat in patients with familial combined hyperlipidaemia: relation to parameters of lipid and carbohydrate metabolism |
| ISRCTN | ISRCTN34596899 |
| ClinicalTrials.gov identifier | |
| Public title | A pilot study to investigate the effect of pioglitazone on muscle and liver triglyceride content and total body fat in patients with familial combined hyperlipidaemia: relation to parameters of lipid and carbohydrate metabolism |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | N/A |
| 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. |
| Lay summary | |
| Ethics approval | Research Ethics Committee approval No. 2002/6480 |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Familial Combined Hyperlipidaemia |
| Participants - 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 |
| Participants - 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.) |
| Anticipated start date | 18/12/2002 |
| Anticipated end date | 30/06/2006 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 26 |
| Interventions | Treatment with pioglitazone versus placebo |
| Primary outcome measure(s) | 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 measure(s) | 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 |
| Sources of funding | Medical Research Council and J Coller Foundation (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Rossi Naoumova |
| Address |
MRC Clinical Sciences Centre
Hammersmith Hospital Du Cane Road |
| City/town | London |
| Zip/Postcode | W12 0NN |
| Country | United Kingdom |
| Sponsor | Medical Research Council (UK) |
| Address |
Clinical Sciences Centre
Hammersmith HospitalMedical Du Cane Road |
| City/town | London |
| Zip/Postcode | W12 0NN |
| Country | United Kingdom |
| Sponsor website: | http:\\www.mrc.ac.uk |
| Date applied | 29/07/2005 |
| Last edited | 10/05/2011 |
| Date ISRCTN assigned | 13/09/2005 |
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