Tokyo, Dec. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060145) titled 'Effects of individualized dietary advice using a dietary questionnaire for adults with type 2 diabetes in a small medical institution: A multicenter randomized clinical trial' on Dec. 20.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - No treatment

Primary Sponsor: Institute - The Jikei University School of Medicine, Tokyo, Japan

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

Objective: Narrative objectives1 - A randomized controlled trial will examine the effects of individualized dietary advice based on food and nutrient intakes using dietary questionnaire for adults with type 2 diabetes in small medical institutions (hospitals or clinics with 99 or fewer general beds). Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - The intervention group will receive dietary advice using the BDHQ individual feedback sheet from their physician approximately two to three times in six months, depending on the frequency of outpatient visits to their physician. Interventions/Control_2 - The control group will not receive the BDHQ feedback sheets, and the sheets will not be disclosed to either the physician or the patient. Patients receive dietary advice to what the physician notices during the interview. Neither group will receive dietary advice from a dietitian during the intervention and follow-up periods.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Adults diagnosed with type 2 diabetes. They must have received and understood a full explanation of the purpose and contents of this study and must have given their free and voluntary consent in writing. Key exclusion criteria - Pregnant women, those with severe renal dysfunction (overt proteinuria or end-stage renal failure), and those who withdraw their consent to participate during the study period. Target Size - 220

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2022 Year 08 Month 28 Day Date of IRB - 2022 Year 10 Month 11 Day Anticipated trial start date - 2022 Year 11 Month 01 Day Last follow-up date - 2024 Year 04 Month 15 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055551

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