Tokyo, April 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061238) titled 'Exploratory study on the safety of yogurt ingestion and glycemic variability using FreeStyle Libre 2 in patients with type 2 diabetes' on April 13.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - THE PHAGE, Inc.

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

Objective: Narrative objectives1 - This study aims to investigate the safety and the effects on glycemic variability of long-term (12-week) ingestion of yogurt in patients with type 2 diabetes receiving standard treatment (metformin). Utilizing the FreeStyle Libre 2 system and a dietary management app, we will exploratorily evaluate effects such as the suppression of postprandial glucose spikes, while confirming safety aspects including the risk of hypoglycemia and the impact on hepatic and renal functions under concomitant use of metformin. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Yogurt:Yes Interventions/Control_2 - Yogurt:No

Eligibility: Age-lower limit - 35 years-old < Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Japanese patients with type 2 diabetes aged 35 years or older (regardless of sex). 2.Patients taking metformin (including combination drugs). 3.Patients with HbA1c < 8.0%. 4.Patients who own a smartphone. Key exclusion criteria - 1.Women who are pregnant, breastfeeding, or may be pregnant. 2.Patients with severe hepatic or renal diseases. 3.Patients with a milk allergy. 4.Patients who are judged to have difficulty maintaining compliance during the study period. 5.Patients using implantable medical devices such as pacemakers. 6.Patients who plan to remove the FreeStyle Libre 2 sensor during the study period (e.g., for health checkups). Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 19 Day Date of IRB - 2026 Year 03 Month 29 Day Anticipated trial start date - 2026 Year 04 Month 14 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070066

Disclaimer: Curated by HT Syndication.