Tokyo, Nov. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063485) titled 'A Study on the Remission of Diabetes and Prediabetes Through Early Lifestyle Intervention for Individuals Diagnosed with Diabetes or Prediabetes During Health Screenings' on Nov. 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Asama General Hospital
Condition:
Condition - Individuals newly identified with diabetes or prediabetes at health screening
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To assess diabetes remission at 12 months after a 12-month lifestyle intervention and remission maintenance or relapse during a further 24 months of follow-up. Improvement in prediabetes will be evaluated separately (proposed amendment).
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Dietary intervention targeting 1,200-1,500 kcal/day and approximately 130 g/day or less of carbohydrates; at least 150 minutes/week of aerobic activity; monthly outpatient follow-up.
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1. Individuals aged 20 years or older and younger than 75 years.
2. Individuals identified as having diabetic-range hyperglycemia or prediabetes during a health checkup.
3. Individuals diagnosed with type 2 diabetes or prediabetes following further evaluation at our hospital.
4. Both individuals who seek medical care promptly after the health checkup and those who have not previously sought medical care despite abnormal findings and subsequently visit our hospital for the first time are eligible.
5. Individuals who provide written informed consent to participate in the study.
Key exclusion criteria - Clear insulin dependence (e.g., low C-peptide), severe liver disease, renal failure, malignancy, or investigator judgment of ineligibility.
Target Size - 20
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 02 Month 26 Day
Date of IRB - 2026 Year 03 Month 13 Day
Anticipated trial start date - 2026 Year 11 Month 01 Day
Last follow-up date - 2031 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072591
Disclaimer: Curated by HT Syndication.
