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

NCT05459701 — Phase 4, Completed, 50 participants, Rehab Werida
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The Hepato-protective Effect of Dapagliflozin in Type 2 Diabetes Mellitus Patients (T2DM) With Nonalcoholic Fatty Liver Disease (NAFLD)

RegistryNCT05459701
StatusCompleted
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment50 (Actual)
SponsorRehab Werida (Other); collaborators: University of Alexandria
ConditionsNonalcoholic Fatty Liver Disease, Type 2 Diabetes
InterventionsDapagliflozin 10mg Tab, Placebo (Drug, other)
Datesstart 2022-05-01, primary completion 2024-06-30, completion 2024-07-31, first posted 2022-07-15, last updated 2025-02-04
Locations1 site in Egypt

Related Papers Related Patents Related Grants Related Experts
All trials for Nonalcoholic Fatty Liver Disease All trials for Type 2 Diabetes All trials of Dapagliflozin 10mg Tab All trials of Placebo

-Summary

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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
group (A) for controlled (placebo).Placebo comparatorOther: Placebo25 patients will recieve placebo for 6 months.
group (D) for Dapagliflozin.Active comparatorDrug: Dapagliflozin 10mg Tab25 patients will recieve 10 mg Dapagliflozin daily for 6 months.
  • Dapagliflozin 10mg Tab (Drug), also known as Dapagliflozin 10 mg.: Dapagliflozin 10 mg once daily for 24 weeks.
  • Placebo (Other): Placebo

+Outcome measures

Primary outcomes

  • leptin (ng/ml) [6 months]: leptin by enzyme-linked immunosorbent assay (ELISA).
  • adiponectin (pg/ml) [6 months]: adiponectin by enzyme-linked immunosorbent assay (ELISA).
  • VCAM-1 (ng/ml) [6 months]: VCAM-1 was analyzed in serum using the human VCAM-1 ELISA kits.

+Eligibility

Sex: All, ages: 20 Years to 75 Years

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.

+Locations (1)

FacilityCityCountryStatus
Rehab Hussein WeridaDamanhūr, ElbehairahEgypt

+Publications

  • 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. PMID 26963613
  • Results publication: 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. PMID 23707905
  • Results publication: 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. PMID 26914659

+Investigators