UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030766 |
|---|---|
| Receipt number | R000035130 |
| Scientific Title | The multifaceted investigation for the beneficial effect of improvement of postprandial hyperglycemia on development of frailty or sarcopenia |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2021/07/16 11:04:58 |
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Basic information
Public title
The multifaceted investigation for the beneficial effect of improvement of postprandial hyperglycemia on development of frailty or sarcopenia
Acronym
The beneficial effect of improvement of postprandial hyperglycemia on frailty or sarcopenia
Scientific Title
The multifaceted investigation for the beneficial effect of improvement of postprandial hyperglycemia on development of frailty or sarcopenia
Scientific Title:Acronym
The beneficial effect of improvement of postprandial hyperglycemia on frailty or sarcopenia
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the association between glycemic variability and frailty or sarcopenia and if improving postprandial hyperglycemia can prevent decreasing muscle mass and strength, physical functions and cognitive or psychological functions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes of phenotypes related to frailty or sarcopenia according to the interventions for improvement of postprandial hyperglycemia 6 months after initiation of interventions
Key secondary outcomes
1) the relationship between the indexes of glycemic variability (SD, MAGE(Mean Amplitude Glycemic Excursions), MODD(Mean of Daily Difference of Blood Glucose)) and phenotypes related to frailty or sarcopenia
2) changes of HbA1c and fasting blood glucose level
3) changes of the indexes of glycemic variability (SD, MAGE, MODD)
4) changes of values of comprehensive geriatric assessments associated with improvement of postprandial hyperglycemia
5) changes of balancing abilities associated with improvement of postprandial hyperglycemia
6) changes of muscle thickness and echo intensity by muscle ultrasonography associated with improvement of postprandial hyperglycemia
7) changes of serum concentrations of myokines (IGF-1, IL-6) associated with improvement of postprandial hyperglycemia
8) changes of urine concentrations of pentosidine and 8-OhdG associated with improvement of postprandial hyperglycemia
9) falls during this investigation
10) adverse events and side effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
Dietary & Exercise intervention
Dietary:Eating vegetables or proteins before cardohydrates or taking unsaturated fatty acid
Exercise:Resistance training for 20 minutes about 45 minutes after every meal
Interventions/Control_2
Drug intervention:GLUBES combination tablet, 3times a day just before every meals)
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
1) the subjects aged 65 years or older with type 2 diabetes treated with DPP-4 inhibitors
2) the subjects diagnosed as 'pre-fraility' by CHS classification of frailty
3) the subjects treated without or can stop treatment with the drugs as follows:sulfonylureas, glinides, alpha-glucosidases and GLP-1 analogs
4) the subjects with 200mg/dl or over of adlib blood glucose level (>twice a week)
Key exclusion criteria
1) the subjects with type 1 diabetes
2) the subjects with HbA1c less than 7.5%
3) the subjects with uncontrolled hypertension (SBP >= 160mmHg)
4) the subjects with effort angina, chronic heart failure and tachyarrhythmia
5) the subjects with chronic respiratory failure
6) the subjects not able to walk by themselves
7) the subjects with chronic kidney disease
8) the subjects with severe hepatic dysfunction
9) the subjects not preserved basic ADL and instrumental ADL
10) the subjects with cognitive impairment
11) the subjects with gastrointestinal surgery
12) the subjects participating other clinical investigations
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Sugimoto |
Organization
Osaka University Graduate School of Medicine
Division name
Geriatric and General Medicine
Zip code
565-0871
Address
2-2, Yamada-oka, Suita, Osaka
TEL
06-6879-3852
sugimoto@geriat.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Akasaka |
Organization
Osaka University Graduate School of Medicine
Division name
Geriatric and General Medicine
Zip code
565-0871
Address
2-2, Yamada-oka, Suita, Osaka
TEL
06-6879-3852
Homepage URL
http://www.med.osaka-u.ac.jp/pub/geriat/www/jmeder.html
akasaka@geriat.med.osaka-u.ac.jp
Sponsor or person
Institute
Geriatric and General Medicine, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kissei Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Osaka University Hospital
Address
2-2, Yamadaoka, Suita, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-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
| 2018 | Year | 02 | Month | 01 | 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
| 2018 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2018 | Year | 01 | Month | 11 | Day |
Last modified on
| 2021 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035130
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| Registered date | File name |
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