Effects of liver fibrosis on insulin resistance and beta-cell function in patients with type 2 diabetes: a cross-sectional study

Effects of liver fibrosis on insulin resistance and beta-cell function in patients with type 2 diabetes: a cross-sectional study - ELFONIR-beta study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000026204

Enrollment

100

Registered

2017-04-03

Start date

2017-04-03

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Type 2 diabetes 2. Impairment of liver function 3. 20 years to 84 years 4. Fasting plasma glucose level between 63 mg/dL and 200 mg/dL 5. Daily consumption of alcohol <30 g/day in men and <20 g/day in women 6. Receiving stable diabetes treatment over 8 weeks

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetes or secondary diabetes 2. Contraindicate for magnetic resonance imaging 3. Thyroid function disorder 4. Viral hepatitis 5. Autoimmune hepatitis 6. Primary biliary cirrhosis 7. Drug-induced liver injury 8. Metabolic liver disease 9. Advanced renal dysfunction 10. Malignant neoplasm 11. steroid medication 12. Pregnant or willing to be pregnant 13. Unable to obtain informed consent to this study 14. Decided as inappropriate for participating in this study by physician

Design outcomes

Primary

Measure	Time frame
The relationship between hepatic MR elastography and insulin resistance in regression analysis	—

Secondary

Measure	Time frame
The relationship between hepatic MR elastography and the following items 1. HOMA2-%B 2. Fasting C-peptide 3. HbA1c 4. Glycated albumin 5. Glycated albumin/HbA1c ratio 6. Fasting plasma glucose 7. 2-hour postprandial glucose 8. Lipid profile 9. AST, ALT, gamma-GTP 10. eGFR, Urine albumin 11. Fib-4 index 12. serum iron, ferritin 13. Type IV collagen 7s domain 14. Hyaluronic acid 15. M2BPGi 16. Body weight 17. Waist circumference 18. BMI 19. Blood pressure 20. Diabetic complication 21. Diabetes treatment The relationship between fatty liver assessed by MRI and the following items 1. HOMA2-IR 2. HOMA2-%B 3. Fasting C-peptide 4. HbA1c 5. Glycated albumin 6. Glycated albumin/HbA1c ratio 7. Fasting plasma glucose 8. 2-hour postprandial glucose 9. Lipid profile 10. AST, ALT, gamma-GTP 11. eGFR, Urine albumin 12. Fib-4 index 13. serum iron, ferritin 14. Type IV collagen 7s domain 15. Hyaluronic acid 16. M2BPGi 17. Body weight 18. Waist circumference 19. BMI 20. Blood pressure 21. Diabetic complication 22. Diabetes treatment The relationship between fatty pancreas assessed by MRI and the following items 1. HOMA2-IR 2. HOMA2-%B 3. Fasting C-peptide 4. HbA1c 5. Glycated albumin 6. Glycated albumin/HbA1c ratio 7. Fasting plasma glucose 8. 2-hour postprandial glucose 9. Lipid profile 10. AST, ALT, ganmma-GTP 11. eGFR, Urine albumin 12. Fib-4 index 13. serum iron, ferritin 14. Type IV collagen 7s domain 15. Hyaluronic acid 16. M2BPGi 17. Body weight 18. Waist circumference 19. BMI 20. Blood pressure 21. Diabetic complication 22. Diabetes treatment	—

Measure

Time frame

The relationship between hepatic MR elastography and the following items 1. HOMA2-%B 2. Fasting C-peptide 3. HbA1c 4. Glycated albumin 5. Glycated albumin/HbA1c ratio 6. Fasting plasma glucose 7. 2-hour postprandial glucose 8. Lipid profile 9. AST, ALT, gamma-GTP 10. eGFR, Urine albumin 11. Fib-4 index 12. serum iron, ferritin 13. Type IV collagen 7s domain 14. Hyaluronic acid 15. M2BPGi 16. Body weight 17. Waist circumference 18. BMI 19. Blood pressure 20. Diabetic complication 21. Diabetes treatment The relationship between fatty liver assessed by MRI and the following items 1. HOMA2-IR 2. HOMA2-%B 3. Fasting C-peptide 4. HbA1c 5. Glycated albumin 6. Glycated albumin/HbA1c ratio 7. Fasting plasma glucose 8. 2-hour postprandial glucose 9. Lipid profile 10. AST, ALT, gamma-GTP 11. eGFR, Urine albumin 12. Fib-4 index 13. serum iron, ferritin 14. Type IV collagen 7s domain 15. Hyaluronic acid 16. M2BPGi 17. Body weight 18. Waist circumference 19. BMI 20. Blood pressure 21. Diabetic complication 22. Diabetes treatment The relationship between fatty pancreas assessed by MRI and the following items 1. HOMA2-IR 2. HOMA2-%B 3. Fasting C-peptide 4. HbA1c 5. Glycated albumin 6. Glycated albumin/HbA1c ratio 7. Fasting plasma glucose 8. 2-hour postprandial glucose 9. Lipid profile 10. AST, ALT, ganmma-GTP 11. eGFR, Urine albumin 12. Fib-4 index 13. serum iron, ferritin 14. Type IV collagen 7s domain 15. Hyaluronic acid 16. M2BPGi 17. Body weight 18. Waist circumference 19. BMI 20. Blood pressure 21. Diabetic complication 22. Diabetes treatment

—

Countries

Japan

Contacts

Public ContactShingo Kato

Yokohama City University Graduate School of Medicine Department of Gastroenterology and Hepatology

shin800m@yokohama-cu.ac.jp045-787-2640

Outcome results