Tokyo, March 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060577) titled 'Combined Use of BMI and Body Muscle-to-Fat Ratio (BMFR) for Identifying High-Risk Patients with Diabetes Mellitus' on March 1.
Study Type:
Observational
Primary Sponsor:
Institute - Jinnouchi Hospital
Condition:
Condition - Type 2 Diabetes Mellitus
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine whether the combination of BMI and BMFR can identify cardiovascular high risk patients who are not detected by BMI alone, and to develop a novel algorithm based on the combination of BMI and BMFR for risk stratification
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - Patients with type 2 diabetes mellitus treated at our clinic
Aged 18 years or older
Those who underwent body composition assessment enabling measurement of skeletal muscle mass and fat mass
Individuals in whom BMI and BMFR can be calculated
Patients whose medical records allow assessment of hypertension, dyslipidemia, fatty liver, chronic kidney disease, and hyperuricemia
Key exclusion criteria - Patients with missing body composition data
Individuals in whom body composition measurement is contraindicated
Patients with active malignancy
Those with marked fluid imbalance due to severe heart failure, liver failure, or renal failure
Patients judged inappropriate for inclusion by the investigator
Target Size - 118
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 01 Day
Anticipated trial start date - 2026 Year 03 Month 01 Day
Last follow-up date - 2027 Year 04 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069288
Disclaimer: Curated by HT Syndication.
