Unique ID issued by UMIN | UMIN000023247 |
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Receipt number | R000026784 |
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 | 2016/08/01 |
Last modified on | 2018/01/11 15:55:00 |
The multifaceted investigation for the beneficial effect of improvement of postprandial hyperglycemia on development of frailty or sarcopenia
The beneficial effect of improvement of postprandial hyperglycemia on frailty or sarcopenia
The multifaceted investigation for the beneficial effect of improvement of postprandial hyperglycemia on development of frailty or sarcopenia
The beneficial effect of improvement of postprandial hyperglycemia on frailty or sarcopenia
Japan |
type 2 diabetes mellitus
Endocrinology and Metabolism | Geriatrics |
Others
NO
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
Efficacy
The changes of phenotypes related to frailty or sarcopenia according to the interventions for improvement of postprandial hyperglycemia 6 months after initiation of interventions
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 values of comprehensive geriatric assessments associated with improvement of postprandial hyperglycemia
3) changes of balancing abilities associated with improvement of postprandial hyperglycemia
4) changes of muscle thickness and echo intensity by muscle ultrasonography associated with improvement of postprandial hyperglycemia
5) changes of serum concentrations of myokines (IGF-1, IL-6) associated with improvement of postprandial hyperglycemia
6) changes of urine concentrations of pentosidine and 8-OhdG associated with improvement of postprandial hyperglycemia
7) falls during this investigation
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
No treatment
3
Prevention
Medicine | Behavior,custom |
dietary intervention:eating vegetables or proteins before cardohydrates or taking unsaturated fatty acid
drug intervention:glinides (Mitiglinide 10mg/time, 3times a day just before every meals or Repaglinide 0.25mg/time, 3times a day just before every meals)
exercise intervention:resistance training for 20 minutes about 45 minutes after every meal
65 | years-old | <= |
Not applicable |
Male and Female
1) the subjects aged 65 years or older with type 2 diabetes
2) the subjects diagnosed as 'pre-fraility' by CHS classification of frailty
3) the subjects treated with long-acting insulin and oral antihyperglycemic drugs (BOT; Basal supported Oral Therapy) or GLP-1 analogs and not treated with or can stop treatment with the drugs as follows:sulfonylureas, glinides, alpha-glucosidases and rapid-acting insulins
4) the subjects with 200mg/dl or over of postprandial blood glucose level (>3times a week) under the treatments using drugs shown in(3)
1) the subjects with type 1 diabetes
2) the subjects with HbA1c less than 7% or larger than 8.5%
3) the subjects performing proper dietary or exercise intervention
4) the subjects with uncontrolled hypertension (SBP >= 160mmHg)
5) the subjects with effort angina, chronic heart failure and tachyarrhythmia
6) the subjects with chronic respiratory failure
7) the subjects not able to walk by themselves
8) the subjects with chronic kidney disease
9) the subjects with severe hepatic dysfunction
10) the subjects not preserved basic ADL and instrumental ADL
11) the subjects with cognitive impairment
12) the subjects with gastrointestinal surgery
13) the subjects participating other clinical investigations
30
1st name | |
Middle name | |
Last name | Ken Sugimoto |
Osaka University Graduate School of Medicine
Geriatric and General Medicine
2-2, Yamada-oka, Suita, Osaka
06-6879-3852
sugimoto@geriat.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Hiroshi Akasaka |
Osaka University Graduate School of Medicine
Geriatric and General Medicine
2-2, Yamada-oka, Suita, Osaka
06-6879-3852
akasaka@geriat.med.osaka-u.ac.jp
Geriatric and General Medicine, Osaka University Graduate School of Medicine
Geriatric and General Medicine, Osaka University Graduate School of Medicine
Other
NO
2016 | Year | 08 | Month | 01 | Day |
Unpublished
Terminated
2016 | Year | 07 | Month | 13 | Day |
2017 | Year | 10 | Month | 01 | Day |
2016 | Year | 07 | Month | 20 | Day |
2018 | Year | 01 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026784
Research Plan | |
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Registered date | File name |
2016/10/21 | 研究計画書 フレイルと食後血糖(修正後).doc |
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