ifestyle induced weight loss and Liraglutide in the treatment of NASH
- Conditions
- on-alcoholic steatohepatitis (NASH)Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2016-002045-36-GB
- Lead Sponsor
- niversity of Oxford, Clinical Trials and Research Governance
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
Non-diabetic (HbA1c <48mmol/mol)
BMI 25-40kg/m2
Age 18-75years
Diagnosis of NAFLD (hepatic steatosis on imaging or histology)
ALT = 1.5 ULN & <10 ULN on 2 occasions >7 days apart and or
Historical liver biopsy showing NASH and/or =F1 fibrosis or NFS = -1.455 OR Fib-4 = 1.3 OR Fibroscan =8kPa.
Non-pregnant, not planning pregnancy
BP<160/100mmHg – stable antihypertensive therapy for 6 months
No weight change >10% within the preceding 3 months
Normal renal function
No contraindications to Lifestyle or Liraglutide
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
• Age <18 or >75years
• Body mass index <25 or >40kg/m2
• A diagnosis of diabetes (type 1 or type 2)
• Use of anti-diabetic or weight loss medications or a GLP-1 agonist such as Liraglutide)
• Contra-indication to Liraglutide
• A blood haemoglobin <120mg/dL
• History of alcoholism or a greater than recommended alcohol intake (Recommendations > 21 drinks on average per week for men and > 14 drinks on average per week for women
• Pregnant or nursing mothers
• History of severe claustrophobia
• Presence of metallic implants, pacemaker that are contra-indications to MRI scanning
• Haemorrhagic disorders
• Anticoagulant treatment
• Other co-morbidities that in the eyes of the investigators may affect data collection
• A medical condition in the opinion of the investigator that might impact upon safety or validity of the results
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine if treatment with Liraglutide improves liver fat and inflammation (non-alcoholic steatohepatitis, NASH), more than matched weight loss alone;Secondary Objective: Investigate changes in:<br>1. the rate of hepatic de-novo lipogenesis (new fat generation and deposition in the liver)<br>2. circulating liver transaminases (liver function markers in the blood)<br>3. liver and peripheral insulin sensitivity and glucose disposal (metabolism)<br>4. adipose (fat) tissue insulin sensitivity <br>5. whole body fat oxidation<br>6. weight and BMI<br>7. body fat and muscle composition<br>;Primary end point(s): Hepatic fat and inflammation measured using multi-parametric MR imaging (abdominal MRI);Timepoint(s) of evaluation of this end point: 12 and 24 weeks.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Change in rate of hepatic de-novo lipogenesis.<br>Change in circulating liver transaminases.<br>Change in hepatic and peripheral insulin sensitivity and glucose disposal.<br>Change in adipose tissue insulin sensitivity.<br>Change in whole body oxidation.<br>Change in weight.<br>Change in body composition.<br>Change in urinary markers of liver disease.<br>Change in faecal markers of liver disease.;Timepoint(s) of evaluation of this end point: 12 and 24 weeks