type 2 diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Osaka University Graduate School of Medicine Geriatric and General Medicine