The Impact Of SGLT2 -I on Metabolic Dysfunction -Associated Steatotic Liver Disease In Patients With Type 2 Diabetes Mellitus

NCT06117137 | Unknown Phase 3

• 1 other identifier: Soh-Med-23-10-06MD
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study question 1:Could SGLT2-I improve hepatic fibrosis, steatosis, and inflammatory markers in type 2 diabetic patients with Metabolic associated steatotic liver disease Question 2:Which drug of SGLT2-I group is more effective in improving metabolic associated steatotic liver disease in type 2 diabetic patients?

Conditions

Fatty Liver, Nonalcoholic

Keywords

Sglt2-I; Metabolic associated steatotic liver disease; Type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (2)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  6 months

• Number of participants with tight controlled diabetes melitus

  Measurement of glycated hemoglobin, random blood sugar,fasting blood sugar

  6 months

Secondary Outcomes (3)

• Number of participants with changing in liver stiffness measurement (LSM in kPa) measured by vibration-controlled transient elastography

  6 months

• Number of participants with changing Liver and spleen size

  6 months

• Number of participant with changing in inflammatory biomarkers

  6 months

Study Arms (3)

Control group

EXPERIMENTAL

Control group (stander treatment of Type two diabetes mellitus without SGLT2-I )

Drug: SGLT2 inhibitor

Group dapa

EXPERIMENTAL

Dapa group: (stander treatment of type two diabetes mellitus plus Dapagliflozin)

Drug: SGLT2 inhibitor

Group empa

EXPERIMENTAL

Group empagliflozin: stander treatment of type two diabetes mellitus plus empagliflozin

Drug: SGLT2 inhibitor

Interventions

SGLT2 inhibitor DRUG

Group empagliflozin: stander treatment of type two diabetes mellitus plus empagliflozin Group dapa:standard treatment of type 2 Diabetes mellitus and dapagliflozin

Also known as: Empagliflozin ,Dapagliflozin

Control group; Group dapa; Group empa

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women aged ≥20 years old who will be:
• Diagnosed with type 2 diabetes since ≥6 months in accordance with World Health Organization criteria (22); and
• Present with glycated hemoglobin equal to or greater than 7% and less than 10% after at least three months of treatment with metformin monotherapy at the maximal tolerated dosage or sulfonylurea alone or in combination; and
• Diagnosed with Metabolic associated steatotic liver disease

You may not qualify if:

• Diagnosis or signs of type 1 diabetes or non-diabetic patients
• Highly uncontrolled diabetes (HbA1c \>86 mmol/mol \[\>10.0%\])
• BMI ≥40 kg/m2
• Other causes of chronic hepatic steatosis (e.g., Hepatitis B virus ,Hepatitis c virus, autoimmune disease, Wilson disease, drugs, alpha one antitrypsin deficiency).
• Patients use of drugs known to cause hepatic steatosis (e.g., amiodarone, valproate, tamoxifen, methotrexate, steroids)
• Treatment with glucose-lowering drugs that influence liver fat, including thiazolidinediones, α-glucosidase inhibitors, sodium-glucose cotransporter 2 (SGLT2) inhibitors or any glucagon-like peptide-1 receptor agonists during the previous 3 months.
• Detection of biliary duct obstruction based on imaging studies.
• Patients with diagnosis of or clinical features that are suspected for another systemic disease that commonly causes liver disease.
• Patient with history of liver transplantation
• Evidence of cirrhosis (on basis of ultrasonography and MRI) or hepatocellular carcinoma (evidence on triphasic CT or MRI).
• Positive HIV test
• Treatment with vitamin E during the previous 3 months.
• Intolerance or allergy SGLT2-I or any other substance in the tablets.
• Contraindications to SGLT2-I use (history of acute or chronic pancreatitis or pancreatic cancer, or history of recurrent urinary tract or genital infections, current or previous gangrene).
• History of or presence of (as found at Visit 1) any clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study.

Sponsors & Collaborators

• Sohag University: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Central Study Contacts

George Esmat Roshdy, Assistant lecturer

CONTACT

00201226866079; Goarge.kaldes@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer at internal medicine department faculty of medicine sohag university

Model Details: Control group (stander treatment of Type 2 diabetes mellitus without SGLT2-I ) SGLT2-I groups (stander treatment of Type 2 diabetes mellitus plus SGLT2-I )

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: November 3, 2023
• Study Start: November 15, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: November 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share