Relationship between protein intake estimated from 24-hour urine collection method and sarcopenia index in elderly patients with type 2 diabetes

UMIN ID: UMIN000054687

Registered date:19/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Type 2 diabetes, Sarcopenia
• Date of first enrollment: 2024/06/19
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Estimated protein intake based on the 24-hour urine collection method
• Secondary Outcome: Baseline characteristics, blood test, skeletal muscle mass, hand grip strength, sit to stand-five test, ten item personality inventory-Japanese version (TIPI-J), treatment Self-Regulation Questionnaire-Japanese version (TSRQ-J), mini-mental state examination (MMSE), international physical activity questionnaire (IPAQ)

Key inclusion & exclusion criteria

• Age minimum: 65years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. diabetes other than type 2 diabetes 2. eGFR <30 ml/min/1.73m2 3. Those who are on a protein-restricted diet 4. Those who undergo treatment for malignant tumors 5. Those who receive corticosteroids or anabolic steroids 6. Those who receive growth hormone 7. Those who have participated in the previous randomized controlled trial evaluating the efficacy of branched-chain amino acids and soy protein at the University of Tsukuba Hospital. 8. Those who are determined to be inappropriate to participate in this study by the Principal Investigator or a Research Associate.

Related Information

• Primary Sponsor: University of Tsukuba Hospital
• Source(s) of Monetary Support: Japan Society of Metabolism and Clinical Nutrition