Liver Disease in patients with Type-2 Diabetes
Research type
Research Study
Full title
Prevalence of Liver Disease in patients with Type 2 Diabetes Mellitus. Screening policy, economic implications and cost analysis
IRAS ID
251274
Contact name
Pinelopi Manousou
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
na, na
Duration of Study in the UK
6 years, 0 months, 1 days
Research summary
Chronic Liver Disease (CLD) is the only major cause of death still increasing year-on-year in the United Kingdom and worlwide in particular due to three main contributors: Alcoholic Liver Disease (ALD), Non-Alcoholic Fatty Liver Disease (NAFLD) and viral hepatitis.
Non-Alcoholic fatty liver disease (NALFD) is the commonest cause of abnormal liver function tests and may lead to severe scarring of the liver (cirrhosis). Although NAFLD is associated with diabetes the exact how common it is unknown. Moreover, diabetic patients are more likely to develop inflammation in the liver (Non-alcoholic steato-hepatitis, NASH) and cirrhosis for unknown reasons. Possible mechanisms include abnormal signaling by a gut hormone receptor, abnormalities in the types of bacteria in the intestine (dysbiosis) and genetic risk factors.
Screening and diagnosing NAFLD is difficult. Liver biopsy is considered the most reliable way but is invasive, expensive and associated with complications. An ultrasound (USS) technique, Transient Elastography (TE)has been introduced as a ‘non-invasive’ method to quantify scarring through Liver stiffness measurements (LSM). 410 patients with diabetes will be recruited from a community diabetes clinic and undergo a screening process including clinical, physiological, blood, USS and TE tests. Patients with a TE suggestive of fat and scarring will be proposed a liver biopsy as per established clinical practice. How common, and the severity of NAFLD will thereby be accurately defined. Stool, urine and blood will be collected from the recruited patients and stored to investigate gut receptors, dysbiosis and genetic factors. The factors that increase the risk of severe liver disease will be investigated to devise the optimal screening/referral strategies for these patients. Patients without liver disease at baseline will be monitored with USS, bloods and TE, once in a year for 5 years.REC name
London - London Bridge Research Ethics Committee
REC reference
18/LO/1742
Date of REC Opinion
7 Dec 2018
REC opinion
Further Information Favourable Opinion