UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045296 |
|---|---|
| Receipt number | R000051638 |
| Scientific Title | Establishment of a Comprehensive Intervention Program to Extend Healthy Life Expectancy and Improve Quality of Life in Elderly Patients with Type 2 Diabetes |
| Date of disclosure of the study information | 2021/08/31 |
| Last modified on | 2024/08/21 16:02:54 |
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Basic information
Public title
Establishment of a Comprehensive Intervention Program to Extend Healthy Life Expectancy and Improve Quality of Life in Elderly Patients with Type 2 Diabetes
Acronym
Establishment of a Comprehensive Intervention Program to Extend Healthy Life Expectancy and Improve Quality of Life in Elderly Patients with Type 2 Diabetes
Scientific Title
Establishment of a Comprehensive Intervention Program to Extend Healthy Life Expectancy and Improve Quality of Life in Elderly Patients with Type 2 Diabetes
Scientific Title:Acronym
Establishment of a Comprehensive Intervention Program to Extend Healthy Life Expectancy and Improve Quality of Life in Elderly Patients with Type 2 Diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the efficacy of a comprehensive intervention on glycemic control in elderly Japanese patients with type 2 diabetes mellitus
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in HbA1c from the time of enrollment to weeks 16
Key secondary outcomes
1) Achievement rate of target HbA1c from the time of registration to weeks 16.
2) Amount of change in body weight from the time of registration to weeks 16.
3) Change in grip strength from the time of registration to weeks 16.
4) Change in body composition (BIA method) from the time of registration to weeks 16.
5) Change in Food Frequency Questionnaire (FFQ) from the time of registration to weeks 16.
6) Change in DASC-8 from the time of registration to weeks 16.
7) Change in Barthel index from the time of registration to weeks 16.
8) Change in DTR-QOL from the time of registration to weeks 16.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Over a period of four months, lifestyle guidance by doctors and nurses, nutritional guidance by registered dietitians, and exercise guidance by a physical therapists are provided once a month.
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 who meet all of the following criteria are included in this study;
1) Patients with type 2 diabetes mellitus.
2) Male and female aged 65 years or older at giving their consent.
3) Patients whose HbA1c level at the time of consent acquisition is less than 9.0% and who have not achieved the "glycemic control target for elderly diabetes (HbA1c level)" set by the Japan Diabetes Society.
4) Patients with no change in treatment within 3 months of giving their consent.
5) Patients who do not meet the criteria of the Asian Sarcopenia Working Group 2019 for sarcopenia.
6) Patients with grip strength and skeletal muscle mass index (SMI) both below average.
7) Patients with a DASC-8 score of 16 or less
8) Patients who provide their consent in a written form by themselves.
Key exclusion criteria
Patients who fall into any of the following criteria are excluded from participating in the study;
1) Patients with diabetes other than type 2 diabetes.
2) Patients with a history of hospitalization for any disease in the past 6 months.
3) Patients with diabetic retinopathy (patients with proliferative retinopathy, vitreous hemorrhage, or other severe clinical abnormality).
4) Patients with mental disorders.
5) Patients with a habit of consuming alcohol more than 5 days a week.
6) Patients whose latest hemoglobin before giving their consent is less than 11 g/dl.
7) Patients with severe renal dysfunction (eGFR of less than 30 mL/min/1.73m2).
8) Patients with severe hepatic dysfunction (any of ALT, AST or ALP is more than 3 times of Upper Limit of Normal.
9) Patients with acute diabetic complications or severe infections.
10) Patients who have history of malignant tumor within 5 years before giving their consent.
11) Patients with joint symptoms that interfere with daily life.
12) Patients who have difficulty following the instructions of the principal investigator or subinvestigators.
13) Patients who are participating in other clinical studies.
14) Patients with other conditions that the responsible investigator or subinvestigators think inappropriate to participate in the study.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Yabe |
Organization
Gifu University Hospital
Division name
Diabetes Metaphysical Internal Medicine / Immunology & Endocrinology
Zip code
501-1194
Address
1-1 Yanagido, Gifu, Gifu
TEL
058-230-6373
daichan.yabechan@gmail.com
Public contact
Name of contact person
| 1st name | Kengo |
| Middle name | |
| Last name | Yamakawa |
Organization
Gifu University Hospital
Division name
Diabetes Metaphysical Internal Medicine / Immunology & Endocrinology
Zip code
501-1194
Address
1-1 Yanagido, Gifu, Gifu
TEL
0582306373
Homepage URL
yamakawakengo@gmail.com
Sponsor or person
Institute
Gifu University Hospital, Diabetes Metaphysical Internal Medicine / Immunology & Endocrinology
Institute
Department
Personal name
Funding Source
Organization
Japan Association for Diabetes Education and Care
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Committee, Graduate School of Medicine, Gifu University
Address
1-1 Yanagido, Gifu, Gifu
Tel
0582306059
rinri@gifu-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
岐阜大学医学部附属病院（岐阜県）、岐阜市民病院（岐阜県）、松波総合病院（岐阜県）、中部国際医療センター（岐阜県）、岩砂病院・岩砂マタニティ（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 31 | 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
Completed
Date of protocol fixation
| 2021 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 29 | Day |
Last modified on
| 2024 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051638
