Effect on Non-Alcoholic Fatty Liver Disease in Patients With Type 2 Diabetes Mellitus With Gastric Inhibitory Polypeptide/Glucagon Like Peptide-1 Analogue
- Status
- UnknownResults none
- Why it is watched
- non-weight indication: liver, addiction
- Who it enrolls
- age 18 Years to 99 Years; BMI ≥19 required; non-obese participants included; conditions: Non-Alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis; Type 2 Diabetes; Liver Fat
- Interventions
- GIP/GLP-1a
- Conditions
- Non-Alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis; Type 2 Diabetes; Liver Fat
- Phase and size
- Phase 1, Phase 2 · 30 participants
- Dates
- Start 2023-10-01
Primary completion 2024-10 - Sponsor
- Dr Adnan Agha (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- change in liver stiffness in terms of kPa12 months
- Change in Liver fat quantification12 months
02Eligibility
Who can take part
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)
03Change log
Registry changes
No changes recorded since the trial was added.