Dapagliflozin in Type 2 Diabetes Mellitus Patients (T2DM) With Nonalcoholic Fatty Liver Disease (NAFLD)
NCT ID: NCT05459701
Last Updated: 2025-02-04
Study Results
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Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2022-05-01
2024-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
-Patients will be randomly allocated into two equal groups (25 patients each); group (A) for controlled (placebo), and the other group (D) for Dapagliflozin.
TREATMENT
DOUBLE
Study Groups
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group (A) for controlled (placebo).
25 patients will recieve placebo for 6 months.
Placebo
Placebo
group (D) for Dapagliflozin.
25 patients will recieve 10 mg Dapagliflozin daily for 6 months.
Dapagliflozin 10mg Tab
Dapagliflozin 10 mg once daily for 24 weeks.
Interventions
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Dapagliflozin 10mg Tab
Dapagliflozin 10 mg once daily for 24 weeks.
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
75 Years
ALL
No
Sponsors
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University of Alexandria
OTHER
Rehab Werida
OTHER
Responsible Party
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Rehab Werida
Associate Professor
Principal Investigators
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Rehab H Werida, Ass Prof.
Role: STUDY_CHAIR
Damanhour University
Amira B. Kassem, Lecturer
Role: PRINCIPAL_INVESTIGATOR
Damanhour University
Yasmin Essam, Bachlor
Role: PRINCIPAL_INVESTIGATOR
Damanhour University
Locations
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Rehab Hussein Werida
Damanhūr, Elbehairah, Egypt
Countries
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References
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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.
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.
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.
Other Identifiers
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Dapagliflozin in NAFLD
Identifier Type: -
Identifier Source: org_study_id
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