Diabetes Type 2, NAFLD
Conditions
Brief summary
The liver is a key organ in metabolism and contributes to T2DM development and insulin resistance via unclear mechanisms that may involve liver fat accumulation, inflammatory signals, and immune cells are proposed to play an important role in the pathogenesis of both NAFLD and T2DM.
Detailed description
This study aims to define * The effects of PTX, Empagliflozin as an example of SGLT-2 inhibitors and UDCA on liver biomarkers and liver steatosis in type 2 diabetic patients. * Studying PTX, Empagliflozin as an example of SGLT-2 inhibitors and UDCA efficacy and safety as add-on therapy in type 2 diabetic patients.
Interventions
DRUGEmpagliflozin 25 MG
tablets to be taken orally once a day
DRUGUrsodeoxycholic acid
tablets to be taken orally twice a day
tablets to be taken orally twice a day
OTHERplacebo
just starch tablets without any active agents
Sponsors
Asmaa Abdelfattah Elsayed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are willing to participate in this study * Adults aged ≥ 18 years old presented at the clinic with a confirmed diagnosis of T2DM who are on sulfonylurea for the last 6 months at least and diagnosed with NAFLD.
Exclusion criteria
* • Patients who refused to participate in this trial * Patients diagnosed with Type 1 diabetes * Previous history of alcohol intake * history of recurrent attacks of ketoacidosis in a diabetic patient * Type 2 diabetic patient with kidney dysfunction (estimated eGFR below 60ml/min/1.73m2 or CrCl below 60ml/min) or on dialysis * Previous history of taking medication that may alter either drug efficacy (eg, corticosteroids, oral contraceptives, and thiazide diuretics) * Evidence of another liver disease (viral hepatitis, drug-induced liver disease, autoimmune hepatitis) * Lactating/pregnant female or children ≤ 18 * Any contraindication for Empagliflozin including: 1. History of recurrent attacks of UTI or Genital infection in females 2. History of recurrent foot injuries or infections 3. Type 2 diabetic patient with CV disease especially NYHA classes III/ IV 4. Immunocompromised patients or with a history of inflammatory, immunological, or malignant diseases. * Any contraindication for PTX including: 1. Hypersensitivity to PTX 2. Patients with peptic ulcer disease or tendency for bleeding * Any contraindication for UDCA including: 1. Hypersensitivity to UDCA 2. Patients with biliary disease or hepatobiliary disease (ascites, jaundice) 3. Patients with hepatic encephalopathy or gallstone pancreatitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| liver fat content (percent) | 6-months | measured by MRI-PDFF |
| fatty liver staging (0, I, II, and III) | 6-months | using ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting and 2-hr post-prandial serum glucose (mg/dl) | 6-months | — |
| Lipid profile | 6-months | (serum triglycerides, total cholesterol, LDL, HDL) (mg/dl) |
| Changes in Serum Gamma glutamyl transferase (γ-GT) | 6-months | IU/l |
| Changes in direct and total bilirubin | 6-months | (mg/dl) |
| Changes in total protein and albumin | 6-months | (g/l) |
| Changes in liver enzymes | 6-months | AST (IU/l) and ALT (IU/l) |
| HbA1c (%) | 6-months | — |
Countries
Egypt
Outcome results
None listed