Tokyo, Oct. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059531) titled 'The Effect of a Remote-Supported Anti-Inflammatory Dietary Intervention on Glycemic Control from Pregnancy to the Postpartum Period in Women with Gestational and Pre-Existing Diabetes' on Oct. 31.

Study Type: Interventional

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

Primary Sponsor: Institute - National Hospital Organization Kyoto Medical Center, Clinical Research Institute

Condition: Condition - Gestational diabetes mellitus (GDM), overt diabetes in pregnancy, type 1 diabetes (T1DM), and type 2 diabetes (T2DM) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim of this study is to evaluate the impact of online-supported anti-inflammatory dietary counseling from pregnancy to the postpartum period on postpartum glycemic control and inflammatory/oxidative stress markers in women with gestational diabetes mellitus (GDM), overt diabetes in pregnancy, or pregnancies complicated by type 1 or type 2 diabetes (T1DM/T2DM). Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Dietary Assessment and Nutrition Counseling Based on the Dietary Inflammatory Index (DII)

Eligibility: Age-lower limit - 18 years-old

Gender - Female Key inclusion criteria - 1, Pregnant or postpartum women diagnosed with one of the following: gestational diabetes mellitus (GDM), overt diabetes first recognized during pregnancy, type diabetes mellitus (T1DM), or type 2 diabetes mellitus (T2DM) 2, Singleton pregnancy 3, Individuals expected to continue regular follow-up visits at the diabetes outpatient clinic. 4, Provided written informed consent of their own free will Key exclusion criteria - Individuals not expected to attend regular follow-up visits. Individuals who have difficulty communicating verbally or in writing in Japanese. Individuals considered inappropriate for study participation by the principal investigator or co-investigators. Target Size - 45

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 09 Month 22 Day Date of IRB - 2025 Year 09 Month 22 Day Anticipated trial start date - 2025 Year 10 Month 31 Day Last follow-up date - 2030 Year 10 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068001

Disclaimer: Curated by HT Syndication.