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| Name | Class |
|---|---|
| University of Alexandria | OTHER |
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The aim of this study is to evaluate the effect of dapagliflozin on liver function of patient with NAFLD and T2DM.
Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University.
Ethical committee approval will be obtained from Ethics committee of General Organization for Teaching Hospitals and Institutes.
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.
All participants should agree to take part in this clinical study and will provide informed consent.
Demographic data; age (year), sex (female/male), weight (kg), height (cm), BMI (kg/m2) will be collected.
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).
Measuring outcome:
The ultrasound screening will be done at first examination.
Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
Results, conclusion, discussion and recommendations will be given.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group (A) for controlled (placebo). | Placebo Comparator | 25 patients will recieve placebo for 6 months. |
|
| group (D) for Dapagliflozin. | Active Comparator | 25 patients will recieve 10 mg Dapagliflozin daily for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin 10mg Tab | Drug | Dapagliflozin 10 mg once daily for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| leptin (ng/ml) | leptin by enzyme-linked immunosorbent assay (ELISA). | 6 months |
| adiponectin (pg/ml) | adiponectin by enzyme-linked immunosorbent assay (ELISA). | 6 months |
| VCAM-1 (ng/ml) | VCAM-1 was analyzed in serum using the human VCAM-1 ELISA kits. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rehab H Werida, Ass Prof. | Damanhour University | Study Chair |
| Amira B. Kassem, Lecturer | Damanhour University | Principal Investigator |
| Yasmin Essam, Bachlor | Damanhour University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehab Hussein Werida | Damanhūr | Elbehairah | 31527 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26963613 | Background | Chiba Y, Yamada T, Tsukita S, Takahashi K, Munakata Y, Shirai Y, Kodama S, Asai Y, Sugisawa T, Uno K, Sawada S, Imai J, Nakamura K, Katagiri H. Dapagliflozin, a Sodium-Glucose Co-Transporter 2 Inhibitor, Acutely Reduces Energy Expenditure in BAT via Neural Signals in Mice. PLoS One. 2016 Mar 10;11(3):e0150756. doi: 10.1371/journal.pone.0150756. eCollection 2016. | |
| 23707905 |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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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.
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| Placebo | Other | Placebo |
|
| Tahara A, Kurosaki E, Yokono M, Yamajuku D, Kihara R, Hayashizaki Y, Takasu T, Imamura M, Li Q, Tomiyama H, Kobayashi Y, Noda A, Sasamata M, Shibasaki M. Effects of SGLT2 selective inhibitor ipragliflozin on hyperglycemia, hyperlipidemia, hepatic steatosis, oxidative stress, inflammation, and obesity in type 2 diabetic mice. Eur J Pharmacol. 2013 Sep 5;715(1-3):246-55. doi: 10.1016/j.ejphar.2013.05.014. Epub 2013 May 23. |
| 26914659 | Result | Ohki T, Isogawa A, Toda N, Tagawa K. Effectiveness of Ipragliflozin, a Sodium-Glucose Co-transporter 2 Inhibitor, as a Second-line Treatment for Non-Alcoholic Fatty Liver Disease Patients with Type 2 Diabetes Mellitus Who Do Not Respond to Incretin-Based Therapies Including Glucagon-like Peptide-1 Analogs and Dipeptidyl Peptidase-4 Inhibitors. Clin Drug Investig. 2016 Apr;36(4):313-9. doi: 10.1007/s40261-016-0383-1. |
| D044882 |
| Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |