Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058767) titled 'Study to improve the quality of sarcopenia prevention strategies through effective nutritional therapy in elderly diabetic patients
-An Observational Study to Identify Optimal Nutritional Status for the Prevention of Onset and Progression of Sarcopenia in Elderly Individuals with Diabetes-' on Sept. 1.
Study Type:
Observational
Primary Sponsor:
Institute - National Center for Geriatrics and Gerontology
Condition:
Condition - Type II Diabetes
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to clarify the role of nutritional status including caloric intake and macronutrient (PFC) balance in the onset and progression of sarcopenia among older adults with diabetes.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 65
years-old
Gender - Male and Female
Key inclusion criteria - 1) Diagnosis: Patients diagnosed with type 2 diabetes mellitus
2) Age: Patients aged >=65 and <90 years at the time of consent
3) Sex: No restriction
4) Daily living status: Patients who are independent in activities of daily living and do not meet the criteria for "requiring long-term care" as defined by the Ministry of Health, Labour and Welfare in Japan
5) Medical care setting: Patients receiving outpatient or inpatient care in departments related to lifestyle-related diseases (e.g., internal medicine, diabetology, endocrinology and metabolism, general internal medicine, cardiology)
6) Informed consent: Patients who have provided written informed consent of their own free will, or patients for whom written consent has been obtained from a legally authorized representative
Key exclusion criteria - 1) Patients with type 1 diabetes mellitus
2) Patients with severe renal impairment (creatinine clearance <15 mL/min)
3) Patients with severe hepatic dysfunction (Child-Pugh class C)
4) Patients with acute complications, malignancies, or other serious illnesses
5) Patients who are unable to maintain a standing posture
6) Patients who meet the criteria for "requiring long-term care" as defined by the Ministry of Health, Labour and Welfare of Japan
7) Patients who have received steroid therapy or treatment for malignancy within the past 6 months
8) Patients deemed inappropriate for participation in this study by the principal investigator or co-investigators
Target Size - 160
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 06 Month 30 Day
Date of IRB - 2025 Year 07 Month 25 Day
Anticipated trial start date - 2025 Year 09 Month 01 Day
Last follow-up date - 2027 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066816
Disclaimer: Curated by HT Syndication.