UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048417 |
|---|---|
| Receipt number | R000055182 |
| Scientific Title | Association between sarcopenia, glycemic control and renal function in older patients with diabetes |
| Date of disclosure of the study information | 2022/07/23 |
| Last modified on | 2024/07/20 20:10:31 |
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Basic information
Public title
Association between sarcopenia, glycemic control and renal function in older patients with diabetes
Acronym
Association between sarcopenia, glycemic control and renal function in older patients with diabetes
Scientific Title
Association between sarcopenia, glycemic control and renal function in older patients with diabetes
Scientific Title:Acronym
Association between sarcopenia, glycemic control and renal function in older patients with diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the association between the incidence of sarcopenia, glycemic control and renal function in older patients with diabetes through cross sectional study
Basic objectives2
Others
Basic objectives -Others
To investigate odds ratios for the incidence of sarcopenia according to the CKD stages in older patients with diabetes
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlations between skeletal muscle mass index (SMI), HbA1c and eGFR
Key secondary outcomes
Odds ratios for the incidence of sarcopenia according to the CKD stages; Correlations between SMI, grip strength, gait speed, BMI, total protein, serum albumin, liver function, serum lipids, and urinary albumin
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetic patients aged 65 years and older who underwent bioelectrical impedance analysis measurements in Akita University Hospital between January 2019 and December 2019 (cross sectional study)
Key exclusion criteria
Not applicable
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Fujita |
Organization
Akita University Graduate School of Medicine
Division name
Department of Metabolism and Endocrinology
Zip code
010-8543
Address
1-1-1 Hondo, Akita
TEL
018-884-6769
hirofuji@gipc.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Fujita |
Organization
Akita University Graduate School of Medicine
Division name
Department of Metabolism and Endocrinology
Zip code
010-8543
Address
1-1-1 Hondo, Akita
TEL
018-884-6769
Homepage URL
hirofuji@gipc.akita-u.ac.jp
Sponsor or person
Institute
Department of Metabolism and Endocrinology, Akita University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Akita University Graduate School of Medicine Ethics Committee
Address
1-1-1 Hondo, Akita
Tel
018-884-6461
soken@hos.akita-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
| 2022 | Year | 07 | Month | 23 | 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
112
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Because of the manuscript in preparation, the publication of the study results is delayed.
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 | 03 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 01 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
This study is performed as a cross sectional study.
(1)We analyze the correlations between skeletal muscle mass index (SMI), HbA1c and eGFR in type 2 diabetic patients aged 65 years and older.
(2)We analyze odds ratios for the incidence of sarcopenia according to CKD stages.
(3)We analyze the correlations between SMI, grip strength, gait speed, BMI, total protein, serum albumin, liver function, serum lipids, and urinary albumin.
Management information
Registered date
| 2022 | Year | 07 | Month | 20 | Day |
Last modified on
| 2024 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055182
