UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038446 |
|---|---|
| Receipt number | R000043808 |
| Scientific Title | A retrospective study of clinical characteristics of type 2 diabetes in the elderly with sarcopenia |
| Date of disclosure of the study information | 2019/10/30 |
| Last modified on | 2020/05/26 15:30:29 |
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Basic information
Public title
A retrospective study of clinical characteristics of type 2 diabetes in the elderly with sarcopenia
Acronym
A retrospective study of clinical characteristics of type 2 diabetes in the elderly with sarcopenia
Scientific Title
A retrospective study of clinical characteristics of type 2 diabetes in the elderly with sarcopenia
Scientific Title:Acronym
A retrospective study of clinical characteristics of type 2 diabetes in the elderly with sarcopenia
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate clinical characteristics of type 2 diabetes mellitus in the elderly with sarcopenia
Basic objectives2
Others
Basic objectives -Others
exploratory study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c
Key secondary outcomes
Dominant hand grip strength, mini-mental state examination (MMSE) score, age, sex, body mass index (BMI), waist circumference, and blood pressure. The duration of diabetes mellitus, a family history of diabetes mellitus, current smoking, habitual alcohol use, uses of insulin and statins, a history of hypertension and dyslipidemia, and a history of cardiovascular, cerebrovascular, and peripheral artery diseases. Diabetic peripheral neuropathy, coefficient of variation of the R-R interval (CVR-R), diabetic retinopathy, diabetic nephropathy, maximum intima-media thickness, cardio-ankle vascular indexes, ankle-brachial indexes. Glycated albumin, total lymphocyte count, hemoglobin, albumin, aspartate aminotransferase, alanine aminotransferase, serum creatinine, eGFR, sodium, potassium, chloride, corrected calcium, phosphorus, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and triglyceride, uric acid.
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
Patients with type 2 diabetes mellitus aged 65 years and above, who admitted to Nihon University School Hospital for diabetes education.
Key exclusion criteria
Patients in whom grip strengths were not assessed.
Target sample size
41
Research contact person
Name of lead principal investigator
| 1st name | Midori |
| Middle name | |
| Last name | Fujishiro |
Organization
Nihon University Hospital
Division name
Department of Internal Medicine
Zip code
101-8309
Address
1-6, kandasurugadai, chiyoda-ku, tokyo
TEL
03-3293-1711
fujishiro.midori@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Tanaka |
Organization
Nihon University
Division name
Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine
Zip code
173-8610
Address
30-1 Kamicho, Oyaguchi, Itabashi-ku, Tokyo, Japan
TEL
81-3-3972-8111
Homepage URL
tanaka.sho@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
Nihon University
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
Nihon University Hospital IRB
Address
1-6 Surugadai, Kanda, Chiyoda-ku, Tokyo, Japan
Tel
81-3-3293-1711
tanaka.sho@nihon-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
| 2019 | Year | 10 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2308-3417/5/2/33
Number of participants that the trial has enrolled
41
Results
Patients with a weakened hand grip (n = 21) scored worse on a mini-mental state examination (24.3 vs. 26.5, p = 0.04), showed a higher prevalence of diabetic peripheral neuropathy (76% vs. 40%, p = 0.03), and had a higher serum phosphorus concentration (3.8 vs. 3.3 mg/dL, p < 0.01) compared to those without a weakened hand grip (n = 20). The serum phosphorus concentration was inversely correlated to hand grip strength (r = -0.501, p < 0.001) among the total of 41 patients.
Results date posted
| 2020 | Year | 05 | Month | 26 | Day |
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
| 2019 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study participants are patients with type 2 diabetes mellitus aged 65 years and above, who admitted to Nihon University School Hospital for diabetes education, from August 2018 to July 2019. Overall 43 patients had admitted during study period. 2 patients were excluded because grip strengths were not assessed. According to the criteria of the Asian Working Group for Sarcopenia, patients with hand grip strength <26 kg in men and < 18 kg in women were classified into lower hand grip strength group (n=21). The others were classified into higher hand grip strength group (n=20). Clinical characteristics were compared between two groups.
Management information
Registered date
| 2019 | Year | 10 | Month | 30 | Day |
Last modified on
| 2020 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043808
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/05/26 | UMIN.xlsx |
