Nonalcoholic Fatty Liver Disease, Type 2 Diabetes
Conditions
Brief summary
The aim of this study is to evaluate the effect of dapagliflozin on liver function of patient with NAFLD and T2DM.
Detailed description
1. Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University. 2. Ethical committee approval will be obtained from Ethics committee of General Organization for Teaching Hospitals and Institutes. 3. About 50 patients who are candidate to detect the hepato-protective effect of Dapagliflozin on non- alcoholic fatty disease, will be recruited from Alexandria Teaching Hospital (EL-Mery), General Organization for Teaching Hospitals and Institutes. 4. All participants should agree to take part in this clinical study and will provide informed consent. 5. Demographic data; age (year), sex (female/male), weight (kg), height (cm), BMI (kg/m2) will be collected. 6. Venous blood samples (5 ml will be collected by a sterile syringe then placed in a suitable sterile tube to be centrifuged, the serum will be reserved and stored at -80°C until the analysis) before, and after receiving medication (Dapagliflozin). 7. Measuring outcome: 1. The biochemical tests will be done on the patients are alanine aminotransferase (ALT), aspartate aminotransferase (AST), homeostasis model assessment of insulin resistance (HOMA-IR), Hemoglobin A1C (HbA1C), Low-density lipoproteins (LDL), High-density lipoproteins (HDL), Triglycerides (TG), liver fibrosis score, and complete blood count (CBC). 2. The molecular tests will be done on the patient are soluble vascular cell adhesion molecule-1 (Svcam-1), adipocytes (e.g. adiponectin, leptin). 8. The ultrasound screening will be done at first examination. 9. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. 10. Results, conclusion, discussion and recommendations will be given.
Interventions
OTHERPlacebo
Placebo
DRUGDapagliflozin 10mg Tab
Dapagliflozin 10 mg once daily for 24 weeks.
Sponsors
University of Alexandria
Rehab Werida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
This is a prospective, randomized (1:1), double-blind clinical trial, will be carried out on 50 patients who are candidate to detect the hepato-protective effect of Dapagliflozin on diabetic type 2 patients with non- alcoholic fatty disease (dapagliflozin 10 mg once daily for 24 - 48 weeks -Patients will be randomly allocated into two equal groups (25 patients each); group (A) for controlled (placebo), and the other group (D) for Dapagliflozin.
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Type 2 diabetes mellitus patients. 2. HbA1C \< 8.5. 3. Patients were They were having fatty liver changes on abdominal ultrasound and mild to moderate elevation of serum liver enzymes. 4. BMI more than 30
Exclusion criteria
1. Patients with a history of alcohol, smoking, uncontrolled diabetes. 2. (HbA1c \> 9.0). 3. Pregnancy. 4. Lactation. 5. Hemochromatosis. 6. Thyroid disorders. 7. Renal dysfunction. 8. Cardiac problem. 9. Chronic liver and decompensated liver disease in the form of hepatitis B and C.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VCAM-1 (ng/ml) | 6 months | VCAM-1 was analyzed in serum using the human VCAM-1 ELISA kits. |
| leptin (ng/ml) | 6 months | leptin by enzyme-linked immunosorbent assay (ELISA). |
| adiponectin (pg/ml) | 6 months | adiponectin by enzyme-linked immunosorbent assay (ELISA). |
Countries
Egypt
Outcome results
None listed