Establishment of a Comprehensive Intervention Program to Extend Healthy Life Expectancy and Improve Quality of Life in Elderly Patients with Type 2 Diabetes

Not Applicable

• Conditions: Type 2 diabetes

• Registration Number: JPRN-UMIN000045296
• Lead Sponsor: Gifu University Hospital, Diabetes Metaphysical Internal Medicine / Immunology & Endocrinology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-31
• Last Update Posted: 2 September 2024
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HbA1c from the time of enrollment to weeks 16

Secondary Outcome Measures

Name	Time	Method
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.