UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054359 |
|---|---|
| Receipt number | R000061833 |
| Scientific Title | A Cross-Sectional Study on the Serum Metal Levels in Patients with Type 2 Diabetes Treated with Metformin |
| Date of disclosure of the study information | 2024/05/10 |
| Last modified on | 2025/05/11 09:10:14 |
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Basic information
Public title
A Cross-Sectional Study on the Serum Metal Levels in Patients with Type 2 Diabetes Treated with Metformin
Acronym
A Study on the Serum Metal Levels in Patients with Type 2 Diabetes Treated with Metformin
Scientific Title
A Cross-Sectional Study on the Serum Metal Levels in Patients with Type 2 Diabetes Treated with Metformin
Scientific Title:Acronym
A Study on the Serum Metal Levels in Patients with Type 2 Diabetes Treated with Metformin
Region
| Japan |
Condition
Condition
Type 2 diaebtes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measuring metal-related parameters in patients with and without metformin treatment to elucidate the changes in metal dynamics in patients with type 2 diabetes taking metformin.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparing serum copper levels in patients with type 2 diabetes with and without metformin.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Metformin Treatment Group:
1. Diagnosed with type 2 diabetes at the time of registration.
2. Aged 18 years or older.
3. Has been continuously taking metformin for at least six months at the time of registration.
4. Has provided written informed consent for participation in this study.
Control Group: Non-Metformin Users:
1. Diagnosed with type 2 diabetes at the time of registration.
2. Aged 18 years or older.
3. Has not been taking metformin continuously for at least six months at the time of registration.
4. Has provided written informed consent for participation in this study.
Key exclusion criteria
1. Patients currently taking iron supplements.
2. Patients currently taking zinc supplements.
3. Patients currently taking vitamin B12 supplements.
4. Patients currently taking folic acid supplements.
5. Patients with anemia.
6. Patients who have undergone gastric, duodenal, or small intestine resection (excluding those who have undergone endoscopic mucosal resection or submucosal dissection).
7. Patients who are pregnant or breastfeeding.
8. Patients with malabsorption issues (e.g., chronic pancreatitis, inflammatory bowel disease, malabsorption syndrome).
9. Patients with renal dysfunction (eGFR < 30 mL/min/1.73m2).
10. Patients with cirrhosis.
11. Patients currently undergoing treatment for malignant tumors.
12. Other patients deemed inappropriate for the study by the investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Sakaguchi |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Diabetes and Endocrinology
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-5861
kzhkskgc@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Natsu |
| Middle name | |
| Last name | Otowa-Suematsu |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Diabetes and Endocrinology
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-5861
Homepage URL
suematsu@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Manpei Suzuki Diabetes Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Hospital Clinical and Translational Research Center
Address
7-5-2 Kusunokichou, Chuo-ku, Kobe, Japan
Tel
078-382-6669
kansatsu@med.kobe-u.ac.jp
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
| 2024 | Year | 05 | Month | 10 | 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
199
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
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional observational study
Management information
Registered date
| 2024 | Year | 05 | Month | 10 | Day |
Last modified on
| 2025 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061833
