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| [ ...Back to search results ] | [ Print-friendly version ] |
| A 6 Month Randomised, Double-Blind, Placebo-Controlled, Magnetic Resonance Spectroscopy (MRS) and Imaging Study to Evaluate the Effect of Rosiglitazone on the Intrahepatic and Intramyocellular Lipid content in Subjects with Type 2 Diabetes Mellitus and Non-Alcoholic Fatty Liver Disease |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN51254253 |
| Date ISRCTN assigned | 01/09/2005 |
| Local reference number(s) | N/A |
| Public title | A 6 Month Randomised, Double-Blind, Placebo-Controlled, Magnetic Resonance Spectroscopy (MRS) and Imaging Study to Evaluate the Effect of Rosiglitazone on the Intrahepatic and Intramyocellular Lipid content in Subjects with Type 2 Diabetes Mellitus and Non-Alcoholic Fatty Liver Disease |
| Scientific title | |
| Acronym | RAFL |
| Disease/condition/study domain | Type 2 Diabetic Patients with Non-Alcoholic Fatty Liver Disease |
| Study hypothesis | 1. Changes in fat deposition in the liver are reflected by metabolite abnormalities that can be detected non-invasively by in vivo hepatic 1H MRS 2. Multinuclear in vivo MRS may determine differences in the type of fat deposited in the liver with differing aetiology and allow the progression of steatosis to fibrosis to be followed non-invasively 3. Non-Alcoholic Steatohepatitis (NASH) in Type 2 Diabetic Patients may improve with treatment with Rosiglitazone 4. Dyslipidaemia in non-alcoholic steatohepatitis may be reversed by Rosiglitazone |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Patients with type 2 diabetes 2. Male or female patient who is 30 to 75 years of age, inclusive, at screening 3. Patients who have initiated statin and fibrate therapy at least 6 months prior to screening, and have been receiving a stable dose for at least 3 months prior to screening. Patients not receiving statin or fibrate therapy may enter the study providing that this method of treatment is not required as active treatment for their medical condition at the time of screening. If any of these patients develop the need for statin or fibrate therapy during the course of the study, therapy will be started without the need to withdraw the patient from the study. 4. Female patients must be post-menopausal (i.e. >6 months without menstrual period) or using contraceptive measures 5. Patients with an HbAlc value <10% at screening visit 6. Patients have an elevated alanine aminotransferase activity (ALT) or aspartate aminotransferase activity (AST) or ultrasound appearances of fatty liver |
| Participants - exclusion criteria | 1. Patients who have taken >2 concomitant oral anti-hyperglycaemic agents (i.e. oral combination) within the 3 months prior to the screening visit (visit 1) 2. Patients who have required the chronic use of insulin for glycaemic control 3. Use of any investigational drug or previous exposure to a thiazolidinedione (TZD) or other PPAR-gamma; agonist (e.g. rosiglitazone, troglitazone, pioglitazone, GI262570) within 30 days or 5 half-lives (whichever is longer) preceding the first dose of medication at the start of the study 4. Systolic blood pressure >170 mmHg or diastolic blood pressure >100 mmHg 5. Patients with unstable or severe angina or congestive heart failure. Presence of clinically significant hepatic disease (i.e. patients with ALT, AST, total bilirubin, or alkaline phosphatase >2.5 times the upper limit of the normal laboratory range). 6. Any pre-existing condition or clinically significant abnormality identified on the Screening (visit 1) physical examination, electrocardiogram, ultrasound examination or laboratory tests which, in the judgement of the investigator, would preclude safe completion of the study 7. Clinically significant anaemia defined by haemoglobin concentration <11 g/dl for males or <10 g/dl for females 8. Patients with creatinine >150 umol/l 9. Women who are lactating, pregnant or planning to become pregnant during the course of the study 10. Alcohol or drug abuse within the last 6 months 11. Patients with chronic liver disease such as viral or autoimmune hepatitis and haemochromatosis 12. Patients with a history of claustrophobia (inability to tolerate MR procedure) 13. Pacemakers, cerebral aneurysm clips, claustrophobia or any implantable ferro-magnetic device incompatible with magnetic resonance imaging |
| Patient information material | |
| Anticipated start date | 12/08/2003 |
| Anticipated end date | 31/08/2004 |
| Status of trial | Completed |
| Target number of participants | 20 |
| Interventions | Rosiglitazone (4-8 mg/day)/Placebo |
| Primary outcome measure(s) | The primary aim is to evaluate, using magnetic resonance imaging and spectroscopy (MRI and MRS), the effect of 26 weeks oral treatment with rosiglitazone in comparison to placebo on the change from baseline of intra-abdominal and sub-cutaneous adipose tissue volume, in patients with type 2 diabetes mellitus and non-alcoholic fatty liver disease or steatohepatitis and liver fat content as assessed by MRS. |
| Secondary outcome measure(s) | Secondary objectives are to evaluate the effects of rosiglitazone on the following: glycaemic control, lipids and lipoproteins; insulin sensitivity and secretion using homeostatic model assessment (HOMA); circulating lipoprotein lipase, hepatic lipase, cholesterol ester transferase (CETP) and lecithin cholesterol acyl transferase activity (LCAT) activities; the composition of circulating high density lipoprotein (HDL) and its apolipoprotein A-I (apoA-1) isoforms; biomarkers of systemic inflammation and plaque stability; very low density apolipoprotein B100 (VLDL apoB100) and HDL apoA-I kinetics. |
| Sources of funding | MRC Career Establishment Grant DMEHEPRO2929 |
| Sponsor name | Imperial College London (UK) |
| Sponsor details | Clinical Research Office South Kensington campus London United Kingdom SW7 2AZ |
| Sponsor email | clinical.researchoffice@imperial.ac.uk |
| Sponsor website | http://www.imperial.ac.uk |
| Contact name | Prof Desmond Johnston |
| Contact details | Metabolic Medicine Department 2nd Floor, Mint Wing St Mary's Hospital Winsland Street London United Kingdom W2 1NY |
| Contact telephone | +44 (0)207 886 1209 |
| Contact fax | +44 (0)207 886 1790 |
| Contact email | d.johnston@imperial.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN51254253 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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