Type 2 diabetes
Conditions
Interventions
Drug Therapy
(1) Lotriga Granular Capsules 2g once a day, immediately after meals
(2) Leebact granules: 3 times a day, after meals
Exercise Therapy
Twice a week, approximately 55 minutes of outpatient
Sponsors
KOYAMA HIROYUKI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients 65 years of age or older at the date of enrollment 2) Patients who meet the following sarcopenia diagnostic criteria (based on AWGS2019) Grip strength: 28 kg or less in men and 18 kg or less in women SMI (musculoskeletal index) measured by InBody: 7.0 kg/m2 or less in men and 5.4 kg/m2 or less in women. 3) Patients whose blood samples taken within 2 weeks prior to enrollment meet the following criteria 8.0% > HbA1c > 6.5 4) Patients who provide written consent for participation in the study
Exclusion criteria
Exclusion criteria: 1) Patients with hyperglycemic emergencies, severe infections, major surgeries, or serious trauma within the past 6 months 2) Patients scheduled for surgery within the next 3 months 3) Patients who have already received prescriptions for EPA, EPA/DHA, or BCAA preparations 4) Patients with a history of allergy to EPA, EPA/DHA, or BCAA preparations in the past 5) Patients with bleeding (blood disease, active gastrointestinal ulcer, vitreous hemorrhage, etc.) 6) Patients with inborn errors of metabolism of branched-chain amino acids 7) Patients who are judged to be inappropriate as research subjects by the investigator(s), such as those who have difficulty in outpatient visits, those who are unlikely to be able to receive a certain intensity of rehabilitation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in skeletal muscle index | — |
Secondary
| Measure | Time frame |
|---|---|
| Amount of change in the following items before and after protocol treatment Body weight, BMI Blood pressure, pulse rate GOT, GPT, TP, ALB, T-chol, TG, LDL-chol, HDL-chol, BUN, Cre, HbA1c, glycoalbumin, Cre/cystatin C ratio, ferritin, NT-ProBNP, lipoprotein(a), carnitine, TRACP-5b in blood tests, BAP, somatomedin C TIR/TAR/TBR by FreeStyle Libre SF-36 Questionnaire, Cognitive and Life Functioning Questionnaire (DASC-8), EAT-10 (swallowing screening tool), Questionnaire on Stages of Behavior Change (exercise items only) Grip strength, chair stand test, TUG (Timed Up and Go) test ABI, baPWV T2 relaxation time of mediobasal hypothalamus, putamen, and amygdala in head MRI | — |
Contacts
Public ContactHIROYUKI KOYAMA
Nagoya City University Hospital
Outcome results
None listed