UMIN-CTR Clinical Trial

Basic information
Public title	Effects of liver fibrosis on insulin resistance and beta-cell function in patients with type 2 diabetes: a cross-sectional study
Acronym	ELFONIR-beta study
Scientific Title	Effects of liver fibrosis on insulin resistance and beta-cell function in patients with type 2 diabetes: a cross-sectional study
Scientific Title:Acronym	ELFONIR-beta study
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of liver fibrosis on insulin resistance and beta-cell function in patients with type 2 diabetes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The relationship between hepatic MR elastography and insulin resistance in regression analysis
Key secondary outcomes	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

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key 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
Key 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
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shingo Kato
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa
TEL	045-787-2640
Email	shin800m@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Shingo Kato
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa
TEL	045-787-2640
Homepage URL
Email	shin800m@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Graduate School of Medicine, Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization	Yokohama City University Graduate School of Medicine, Department of Gastroenterology and Hepatology, Department of Endocrinology & Metabolism
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 03 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 02 Month 10 Day
Date of IRB	2017 Year 05 Month 08 Day
Anticipated trial start date	2017 Year 04 Month 03 Day
Last follow-up date	2020 Year 06 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The aim of this cross-sectional study is to investigate the effects of liver fibrosis on insulin resistance and beta-cell function in patients with type 2 diabetes.

Management information
Registered date	2017 Year 02 Month 18 Day
Last modified on	2022 Year 02 Month 23 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030087