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

NCT07020377 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: Dapagliflozin NAFLD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Nonalcoholic fatty liver disease (NAFLD) encompasses conditions such as nonalcoholic steatohepatitis (NASH), which involves liver inflammation and fibrosis resulting from steatosis, potentially leading to cirrhosis and hepatocellular carcinoma. NAFLD is intricately linked to metabolic syndrome, with insulin resistance and hyperinsulinemia as key underlying factors. particularly among individuals with type2 diabetes. NAFLD is an independent risk factor for cardiovascular events, negatively impacting life expectancy in diabetic patients, and it exacerbates insulin resistance and glucose intolerance. Early intervention in diabetes complicated by NAFLD is vital due to associations with hepatocarcinogenesis and macrovascular complications. Sodium-glucose cotransporter2 (SGLT2) inhibitors, which promote glucose excretion and reduce insulin dependence, have shown significant hypoglycemic effects, weight reduction, and potential benefits on liver function. Dapagliflozin, a specific SGLT2 inhibitor, has been proven effective in lowering hyperglycemia in type 2 diabetes and mitigating NAFLD-related complications in animal models. This study aimed to evaluate the impact of dapagliflozin on liver function in NAFLD patients with type2 diabetes. Eligible participants received dapagliflozin for 24weeks, with assessments including body composition, serum biochemistry, and molecular parameters to determine therapeutic outcomes.

Conditions

Diabetes Mellitus; Non Alcholic Fatty Liver Disease

Keywords

Diabetes mellitus type 2; non alcoholic fatty liver disease; hepato-protective; Dapagliflozin

Outcome Measures

Primary Outcomes (4)

• Fibroscan

  Decrease in liver stiffness by measure CAP

  6 months

• soluble vascular cell adhesion molecule-1 (Svcam-1)

  VCAM-1 was analyzed in serum using the human VCAM-1 ELISA kits.

  6 months

• adiponectin

  adiponectin by enzyme-linked immunosorbent assay (ELISA).

  6 months

• leptin

  leptin by enzyme-linked immunosorbent assay (ELISA).

  6 months

Secondary Outcomes (2)

• liver enzymes

  6 months

• Lipid profile

  6 months

Study Arms (3)

Positive control

PLACEBO COMPARATOR

Drug: Placebo

Dapagliflozin 10mg

ACTIVE COMPARATOR

The group which takes the medication (dapagliflozin)

Drug: Dapagliflozin (DAPA)

Negative control

OTHER

healthy participants without any medication

Other: Negative control

Interventions

Dapagliflozin (DAPA) DRUG

dapagliflozin 10mg tab once daily for NAFLD patient

Dapagliflozin 10mg

Placebo DRUG

placebo

Positive control

Negative control OTHER

Baseline sample serum without either drug or placebo

Negative control

Eligibility Criteria

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

You may qualify if:

• Patients with Type 2 diabetes mellitus patients.
• Patients were having fatty liver changes by fibro scan and with mild to moderate elevation of serum liver enzymes or without.
• patients taking insulin or anti-diabetic medications.
• Patients have Renal dysfunction.
• Patients have Cardiac problem

You may not qualify if:

• Patients with a history of alcohol, smoking, uncontrolled diabetes.
• Pregnancy.
• Lactation.
• Chronic liver and decompensated liver disease in hepatitis B and C.
• patients whose abdominal ultrasounds findings were extremely abnormal (mass, fibrosis, ascites, and cirrhosis) and amino transaminase levels were severely high (ALT and AST greater than 15 times the upper limit of normal according to Johns Hopkins Diabetes Guide) suggest severe liver cell injury was also worked for acute viral hepatitis.

Sponsors & Collaborators

• Amira Bisher,PhD: lead
• Alexandria University: collaborator
• Egyptian Liver Hospital: collaborator

Study Sites (2)

Egyptian liver hospital

Al Mansurah, Egypt

Location

Alexandria university main hospital

Alexandria, Egypt

Location

Related Publications (7)

• Bailey CJ, Gross JL, Pieters A, Bastien A, List JF. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial. Lancet. 2010 Jun 26;375(9733):2223-33. doi: 10.1016/S0140-6736(10)60407-2.

  PMID: 20609968 BACKGROUND

• Wu JH, Foote C, Blomster J, Toyama T, Perkovic V, Sundstrom J, Neal B. Effects of sodium-glucose cotransporter-2 inhibitors on cardiovascular events, death, and major safety outcomes in adults with type 2 diabetes: a systematic review and meta-analysis. Lancet Diabetes Endocrinol. 2016 May;4(5):411-9. doi: 10.1016/S2213-8587(16)00052-8. Epub 2016 Mar 18.

  PMID: 27009625 BACKGROUND

• Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17.

  PMID: 26378978 BACKGROUND

• Targher G, Day CP, Bonora E. Risk of cardiovascular disease in patients with nonalcoholic fatty liver disease. N Engl J Med. 2010 Sep 30;363(14):1341-50. doi: 10.1056/NEJMra0912063. No abstract available.

  PMID: 20879883 BACKGROUND

• Tomah S, Hamdy O, Abuelmagd MM, Hassan AH, Alkhouri N, Al-Badri MR, Gardner H, Eldib AH, Eid EA. Prevalence of and risk factors for non-alcoholic fatty liver disease (NAFLD) and fibrosis among young adults in Egypt. BMJ Open Gastroenterol. 2021 Oct;8(1):e000780. doi: 10.1136/bmjgast-2021-000780.

  PMID: 34610926 BACKGROUND

• Lomonaco R, Ortiz-Lopez C, Orsak B, Finch J, Webb A, Bril F, Louden C, Tio F, Cusi K. Role of ethnicity in overweight and obese patients with nonalcoholic steatohepatitis. Hepatology. 2011 Sep 2;54(3):837-45. doi: 10.1002/hep.24483. Epub 2011 Aug 8.

  PMID: 21674556 BACKGROUND

• Browning JD, Szczepaniak LS, Dobbins R, Nuremberg P, Horton JD, Cohen JC, Grundy SM, Hobbs HH. Prevalence of hepatic steatosis in an urban population in the United States: impact of ethnicity. Hepatology. 2004 Dec;40(6):1387-95. doi: 10.1002/hep.20466.

  PMID: 15565570 BACKGROUND

MeSH Terms

Conditions

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

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Yasmine Essam, Bachlor, Clinical pharmacy

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: June 13, 2025
• Study Start: January 15, 2024
• Primary Completion: December 20, 2025
• Study Completion: December 30, 2025
• Last Updated: June 13, 2025

Record last verified: 2024-11

Locations

EG (2)