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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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 obesity 20% 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 treatment There 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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Arab Emirates
Internal Medicine, College of Medicine and Health Sciences
RECRUITING
Al Ain City
Contact Information
Primary
Adnan Agha, FRCP
adnanagha@uaeu.ac.ae
+971-3-7673333
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2025-02
Participants
Target number of participants: 30
Treatments
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
Sponsors
Leads: Dr Adnan Agha

This content was sourced from clinicaltrials.gov