Type 2 diabetes
Conditions
Interventions
Over a period of four months, lifestyle guidance by doctors and nurses, nutritional guidance by registered dietitians, and exercise guidance by a physical therapists are provided once a month.
Sponsors
Gifu University Hospital, Diabetes Metaphysical Internal Medicine / Immunology & Endocrinology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are included in this study; 1) Patients with type 2 diabetes mellitus. 2) Male and female aged 65 years or older at giving their consent. 3) Patients whose HbA1c level at the time of consent acquisition is less than 9.0% and who have not achieved the "glycemic control target for elderly diabetes (HbA1c level)" set by the Japan Diabetes Society. 4) Patients with no change in treatment within 3 months of giving their consent. 5) Patients who do not meet the criteria of the Asian Sarcopenia Working Group 2019 for sarcopenia. 6) Patients with grip strength and skeletal muscle mass index (SMI) both below average. 7) Patients with a DASC-8 score of 16 or less 8) Patients who provide their consent in a written form by themselves.
Exclusion criteria
Exclusion criteria: Patients who fall into any of the following criteria are excluded from participating in the study; 1) Patients with diabetes other than type 2 diabetes. 2) Patients with a history of hospitalization for any disease in the past 6 months. 3) Patients with diabetic retinopathy (patients with proliferative retinopathy, vitreous hemorrhage, or other severe clinical abnormality). 4) Patients with mental disorders. 5) Patients with a habit of consuming alcohol more than 5 days a week. 6) Patients whose latest hemoglobin before giving their consent is less than 11 g/dl. 7) Patients with severe renal dysfunction (eGFR of less than 30 mL/min/1.73m2). 8) Patients with severe hepatic dysfunction (any of ALT, AST or ALP is more than 3 times of Upper Limit of Normal. 9) Patients with acute diabetic complications or severe infections. 10) Patients who have history of malignant tumor within 5 years before giving their consent. 11) Patients with joint symptoms that interfere with daily life. 12) Patients who have difficulty following the instructions of the principal investigator or subinvestigators. 13) Patients who are participating in other clinical studies. 14) Patients with other conditions that the responsible investigator or subinvestigators think inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from the time of enrollment to weeks 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Achievement rate of target HbA1c from the time of registration to weeks 16. 2) Amount of change in body weight from the time of registration to weeks 16. 3) Change in grip strength from the time of registration to weeks 16. 4) Change in body composition (BIA method) from the time of registration to weeks 16. 5) Change in Food Frequency Questionnaire (FFQ) from the time of registration to weeks 16. 6) Change in DASC-8 from the time of registration to weeks 16. 7) Change in Barthel index from the time of registration to weeks 16. 8) Change in DTR-QOL from the time of registration to weeks 16. | — |
Countries
Japan
Contacts
Public ContactKengo Yamakawa
Gifu University Hospital Diabetes Metaphysical Internal Medicine / Immunology & Endocrinology
Outcome results
None listed