Dapagliflozin in Type 2 Diabetes Mellitus Patients (T2DM) With Nonalcoholic Fatty Liver Disease (NAFLD)

Type 2 Diabetes Clinical Trial

Official title:

The Hepato-protective Effect of Dapagliflozin in Type 2 Diabetes Mellitus Patients (T2DM) With Nonalcoholic Fatty Liver Disease (NAFLD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05459701
• Other study ID #: Dapagliflozin in NAFLD
• Status: Recruiting
• Phase: Phase 4
• Start date: May 1, 2022
• Est. completion date: May 10, 2024

Study information

• Verified date: February 2024
• Source: Damanhour University
• Contact: Rehab H Werida, Ass Prof.
• Phone: +201005359968
• Email: rehabwrieda[@]pharm.dmu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the effect of dapagliflozin on liver function of patient with NAFLD and T2DM.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 10, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease
• Type 2 Diabetes

Intervention

Drug:
• Dapagliflozin 10mg Tab
Dapagliflozin 10 mg once daily for 24 weeks.

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Egypt	Rehab Hussein Werida	Damanhur	Elbehairah

Sponsors (2)

Lead Sponsor	Collaborator
Rehab Werida	University of Alexandria

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

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 — View Citation

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 steatosi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	leptin (ng/ml)	leptin by enzyme-linked immunosorbent assay (ELISA).	6 months
Primary	adiponectin (pg/ml)	adiponectin by enzyme-linked immunosorbent assay (ELISA).	6 months
Primary	VCAM-1 (ng/ml)	VCAM-1 was analyzed in serum using the human VCAM-1 ELISA kits.	6 months