The multifaceted investigation for the beneficial effect of improvement of postprandial hyperglycemia on development of frailty or sarcopenia
Not Applicable
Completed
- Conditions
- type 2 diabetes mellitus
- Registration Number
- JPRN-UMIN000030766
- Lead Sponsor
- Geriatric and General Medicine, Osaka University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The changes of phenotypes related to frailty or sarcopenia according to the interventions for improvement of postprandial hyperglycemia 6 months after initiation of interventions
- Secondary Outcome Measures
Name Time Method 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