type 2 diabetes mellitus
Conditions
Interventions
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 Repa
Sponsors
Geriatric and General Medicine, Osaka University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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
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 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 | — |
Countries
Japan
Contacts
Public ContactHiroshi Akasaka
Osaka University Graduate School of Medicine Geriatric and General Medicine
Outcome results
None listed