Familial Combined Hyperlipidaemia Nutritional, Metabolic, Endocrine Hyperlipidaemia
Conditions
Interventions
Sponsors
Medical Research Council (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
Exclusion criteria
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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed