Effect on Non-Alcoholic Fatty Liver Disease in Patients With Type 2 Diabetes Mellitus With Gastric Inhibitory Polypeptide/Glucagon Like Peptide-1 Analogue

Launched by DR ADNAN AGHA · Mar 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called GLP-1 analogue on patients who have both type 2 diabetes and non-alcoholic fatty liver disease (NAFLD). The goal is to see if this treatment can reduce fat in the liver after six months. NAFLD is a common condition, especially in people with type 2 diabetes and obesity, and it can sometimes lead to more serious liver issues. This study is significant because it will be the first randomized trial focused on this treatment in the United Arab Emirates.

To participate in this study, you need to be over 18 years old, have had type 2 diabetes for at least a year, and have advanced fibrosis in your liver (a specific stage of liver damage). You should also be in good overall health and not currently taking certain diabetes medications. If you join, you’ll receive the GLP-1 treatment and undergo regular check-ups to monitor your health and liver fat levels. This research could help create new treatment options for people dealing with non-alcoholic fatty liver disease.

Gender

ALL

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)