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NCT05751720
Effect on Non-Alcoholic Fatty Liver Disease in Patients With Type 2 Diabetes Mellitus With Gastric Inhibitory Polypeptide/Glucagon Like Peptide-1 Analogue
Conditions: Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis, Type 2 Diabetes, Liver Fat
Sex: All
Ages: 18 Years – 99 Years
Phase: PHASE1, PHASE2
Enrollment: 30
Sponsor: Dr Adnan Agha
Location: United Arab Emirates
Summary
Obesity and type 2 Diabetes Mellitus prevalence has doubled in the last 30 years and nearly one fifth of UAE population has Type 2 Diabetes while more than quarter has obesity.Non-alcoholic fatty liver disease is present in more than 30% of patients with type 2 diabetes and in > 50% patient with obesity20% of patients with Non-alcoholic fatty liver disease progress to develop non-alcoholic steatohepatitis which can lead to liver failure and hepatocellular carcinoma.This study aims to use GLP-1 analogue to see effects on liver fat deposition after six months of treatmentThere is no current randomised study on treatment of non-alcoholic steatohepatitis in United Arab Emirates population; so once completed this will the first study.This study will pave the way for developing a treatment pathway for patients with non-alcoholic fatty liver disease.
Eligibility Criteria
Inclusion Criteria:Age > 18; either male or femaleDiagnosed 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 independentlyNot already on GLP-1 analogues or SGLT2 inhibitors or pioglitazoneGood general healthBMI> 19 but less than 40Exclusion Criteria:Known history of alcohol excess or current alcohol use of > 20 g/weekEvidence 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 failureHistory 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 < 30history of heamturia or bladder cancerhistory of osteoporosisALT ≥3.5 times the upper normal limit (UNL)Taking steroids, antipsychotics or progesterone preparationsUncontrolled hypertensionPositive 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)
Source: ClinicalTrials.gov (NCT05751720). StuddyBuddy aggregates publicly available trial information.