Effect on Non-Alcoholic Fatty Liver Disease in Patients With Type 2 Diabetes Mellitus With Gastric Inhibitory Polypeptide/Glucagon Like Peptide-1 Analogue
Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis, Type 2 Diabetes
About this trial
This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease
Eligibility Criteria
Inclusion Criteria: Age > 18; either male or female Diagnosed to have Type 2 Diabetes Mellitus for > 1 year. Presence of NAFLD advanced fibrosis (F3 and F4; defined by NFS of > 0.676) Able to consent independently Not already on GLP-1 analogues or SGLT2 inhibitors or pioglitazone Good general health BMI> 19 but less than 40 Exclusion Criteria: Known history of alcohol excess or current alcohol use of > 20 g/week Evidence of pre-existing liver or biliary disease (hepatoma, biliary tract obstruction; liver cirrhosis secondary to viral infection or immune/ congenital). Known or suspected hypersensitivity to GLP-1 analogues or pioglitazone. Receipt of any investigational medicinal product within 30 days before screening. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive methods. Endocrinopathies (e.g., Cushing syndrome) Personal history of heart disease especially heart failure History of malignant neoplasm within 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed. eGFR < 30 history of heamturia or bladder cancer history of osteoporosis ALT ≥3.5 times the upper normal limit (UNL) Taking steroids, antipsychotics or progesterone preparations Uncontrolled hypertension Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies. HbA1c > 10% Claustrophobia or unable to get MRI due to contraindications (e.g metal in the body) Weight > 150 kg (due to imaging trolley restrictions)
Sites / Locations
- Internal Medicine, College of Medicine and Health Sciences
Arms of the Study
Arm 1
Experimental
GLP-1/GIP Arm pre and post intervention
The adult patients with type 2 diabetes mellitus attending Tawam Hospital Diabetes clinic, who are identified as having fatty liver disease either via ultrasound or biochemical parameter of NFS. We will aim to include minimum 30 patients fulfilling the selection criteria as below. Informed written consent will be obtained . Intervention group will receive GLP-1 analogues (subcutaneous Tirzepatide or oral semaglutide). The blood tests will be done at baseline, 3 months of treatment and at 6 months of treatment. Liver imaging (fibroscan and/or MRI fat measurement) will be done at baseline and at 6 months to see if there is any change.The KPa improvement in liver stiffness and total fat estimation pre and post intervention in both groups will assessed