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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026204
Receipt No. R000030087
Scientific Title Effects of liver fibrosis on insulin resistance and beta-cell function in patients with type 2 diabetes: a cross-sectional study
Date of disclosure of the study information 2017/04/03
Last modified on 2017/02/18

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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
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
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 Preinitiation
Date of protocol fixation
2017 Year 02 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 03 Day
Last follow-up date
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
2017 Year 02 Month 18 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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