UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055820 |
|---|---|
| Receipt number | R000063715 |
| Scientific Title | The investigation of the relationship between sarcopenia and obesity in diabetes, and arteriosclerotic disease. |
| Date of disclosure of the study information | 2024/10/15 |
| Last modified on | 2024/10/07 15:16:42 |
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Basic information
Public title
The investigation of the relationship between sarcopenia and obesity in diabetes, and arteriosclerotic disease.
Acronym
sarcopenia with diabetes research
Scientific Title
The investigation of the relationship between sarcopenia and obesity in diabetes, and arteriosclerotic disease.
Scientific Title:Acronym
sarcopenia with diabetes research
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the prevalence and characteristics of sarcopenia and obesity in Japanese diabetic patients.
Basic objectives2
Others
Basic objectives -Others
The 2nd aim of this study is to examine the relationship between these complications and markers related to diabetes and arteriosclerotic disease.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The prevalence of sarcopenic obesity in diabetes
Key secondary outcomes
Comprehensively examine the correlation between the following items;
Red blood cell count, white blood cell count, white blood cell differential, platelet count, hemoglobin, hematocrit, Total protein, albumin, AST, ALT, gamma GTP, BUN, Cre, estimated GFR (eGFR), glucose, free T3, free T4, TSH, C-peptide, uric acid, BNP, hydroxybutyric acid, LDL cholesterol, HDL cholesterol, triglyceride, HbA1c, Urinary albumin / creatinine rate, L-FABP, urinary glucose, Pulse wave (ABI, CAVI), nerve conduction velocity test, electrocardiogram, CVR-R, Umbilical circumference, grip strength, walking speed (m/sec),In body (body composition meter): Limb skeletal muscle index (SMI), body fat percentage, body fat amount, water content, muscle mass,body weight, BMI, Systolic blood pressure, diastolic blood pressure, pulse rate, Age, gender,Duration of diabetes, stage of retinopathy, presence or absence of neuropathy, stage of nephropathy, stage of CKD, Schellong tests, type of diabetes medication, presence or absence of hypertension, presence or absence of dyslipidemia.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. The diabetes who had admitted to the Department of Endocrinology and Metabolism at Dokkyo Medical University Hospital with diabetes treatment from January 1, 2020 to March 31,2023.
Key exclusion criteria
1.Patients whose sarcopenia could not be evaluated during hospitalization
2.Patients who had muscle wasting disease.
3.Patients who have requested refusal to participate in this study
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Yoshimasa |
| Middle name | |
| Last name | Aso |
Organization
Dokkyo Medical University Hospital
Division name
Department of Endocrinology and metabolism
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Shimotsugagun, Tochigi 321-0293, Japan
TEL
0282861111
yaso@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Toshie |
| Middle name | |
| Last name | Iijima |
Organization
Dokkyo Medical University Hospital
Division name
Department of Endocrinology and metabolism
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Shimotsugagun, Tochigi 321-0293, Japan
TEL
0282861111
Homepage URL
toshieo1213@gmail.com
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University Department of Endocrinology and 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
Dokkyo Medical University Hospital
Address
880 Kitakobayashi, Mibu, Shimotsugagun, Tochigi 321-0293, Japan
Tel
0282-87-2275
r-kenkyu@dokkyomed.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 | 10 | Month | 15 | 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
Suspended
Date of protocol fixation
| 2022 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To analyze 500 cases, assuming an estimated dropout of 100 cases, the target number of cases is set at 600.
Management information
Registered date
| 2024 | Year | 10 | Month | 12 | Day |
Last modified on
| 2024 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063715
