Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Desmond Johnston


Contact details

Metabolic Medicine Department
2nd Floor
Mint Wing
St Mary's Hospital
Winsland Street
W2 1NY
United Kingdom
+44 (0)207 886 1209

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title



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

Ethics approval

Not provided at time of registration

Study design

Randomised, Double-Blind, Placebo-Controlled

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet


Type 2 Diabetic Patients with Non-Alcoholic Fatty Liver Disease


Rosiglitazone (4-8 mg/day) vs placebo

Intervention type



Not Specified

Drug names


Primary outcome measures

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 measures

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.

Overall trial start date


Overall trial end date


Reason abandoned


Participant 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

Participant type


Age group




Target number of participants


Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Metabolic Medicine Department
W2 1NY
United Kingdom

Sponsor information


Imperial College London (UK)

Sponsor details

Clinical Research Office
South Kensington campus
United Kingdom

Sponsor type




Funder type

Research council

Funder name

MRC Career Establishment Grant DMEHEPRO2929 (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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. 2009 results in

Publication citations

  1. Results

    Varghese A, Yee MS, Chan CF, Crowe LA, Keenan NG, Johnston DG, Pennell DJ, Effect of rosiglitazone on progression of atherosclerosis: insights using 3D carotid cardiovascular magnetic resonance., J Cardiovasc Magn Reson, 2009, 11, 24, doi: 10.1186/1532-429X-11-24.

Additional files

Editorial Notes