UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026204 |
|---|---|
| Receipt number | 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 | 2022/02/23 14:33:47 |
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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
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
shin800m@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine,
Department of Gastroenterology and Hepatology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030087
