Tokyo, July 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058452) titled 'Development and Validation of a Predictive Index for Glycemic Control by Trends in Environmental Factors and Body Composition in Patients with Type 2 Diabetes Mellitus' on July 14.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Gunma Paz University

Condition: Condition - Type 2 Diabetes Mellitus Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To develop and validate a synergistic behavioral prediction index (SBPI) combining 50 kHz reactance and neighborhood walking environment scores in newly diagnosed type 2 diabetic patients to assess its predictive accuracy for successful behavior change and achievement of glycemic control in lifestyle interventions. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Standardized lifestyle intervention (dietary therapy + exercise therapy + education)

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Newly diagnosed type 2 diabetes (within 3 months of diagnosis) Age 20-80 Baseline HbA1c 6.5-9.9% (48-85 mmol/mol) Available to participate in lifestyle intervention Key exclusion criteria - Type 1 diabetes or secondary diabetes Pregnant or lactating Serious liver disease (ALT >3 times upper limit of normal) Heart failure (NYHA Class III-IV) Dialysis or eGFR <30 mL/min/1.73m^2 Contraindication to bioelectrical impedance measurement Not obtain informed consent Target Size - 195

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2021 Year 06 Month 20 Day Date of IRB - 2023 Year 06 Month 20 Day Anticipated trial start date - 2022 Year 04 Month 01 Day Last follow-up date - 2023 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066830

Disclaimer: Curated by HT Syndication.