Diabetes, Obesity & Metabolism最新文献

{"title":"Probiotics and dietary fibre fermented milk supplementation initiated in the first trimester to prevent gestational diabetes mellitus in overweight and obese pregnant women: A randomized controlled trial.","authors":"Lirui Zhang, Jia Wang, Wei Zheng, Xianxian Yuan, Cheng Liu, Yan Xin, Wei Song, Xiaoxin Wang, Shengnan Liang, Lijun Chen, Junying Zhao, Yanpin Liu, Guanghui Li","doi":"10.1111/dom.70158","DOIUrl":"https://doi.org/10.1111/dom.70158","url":null,"abstract":"<p><strong>Aims: </strong>To evaluate the effects of intensive dietary and lifestyle (IDL) interventions and probiotic and dietary fibre fermented milk (PFM) supplementation, initiated in the first trimester, on the risk of gestational diabetes mellitus (GDM) and pregnancy outcomes in overweight and obese women.</p><p><strong>Materials and methods: </strong>In this parallel randomized controlled trial, 478 women with a prepregnancy body mass index ≥25 kg/m², enrolled at 6-12⁺⁶ weeks of gestation, were randomly assigned to IDL, PFM, or standard care (SC) groups. The primary outcome was GDM; secondary outcomes included maternal weight changes, pregnancy outcomes, and gut microbiota profiles assessed by 16S rRNA sequencing.</p><p><strong>Results: </strong>GDM incidence was 25.60% in the IDL group (32/125), 18.42% in the PFM group (21/114), and 33.33% in the SC group (39/117) (p = 0.035). PFM reduced GDM risk by 55% compared with SC (OR = 0.45, 95% CI: 0.25-0.83). At the time of the oral glucose tolerance test (OGTT), median weight gain was lower in the IDL group (4.00 kg) than in the PFM (5.20 kg) and SC (5.65 kg) groups (p = 0.009). Correlation analysis revealed that Acidovorax abundance in PFM was negatively associated with OGTT 0 h glucose, while Megasphaera in the SC group was positively correlated with 2-hour post-load glucose (p < 0.05).</p><p><strong>Conclusions: </strong>PFM supplementation initiated in the first trimester reduced GDM incidence. IDL reduced weight gain but had no significant effect on GDM. PFM may be a promising strategy for GDM prevention in these high-risk populations.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145129680","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Diabetes remission and diabetic complications of bariatric surgery vs. medical management in patients with type 2 diabetes: A meta-analysis of randomized controlled trials.","authors":"Jiayu Cheng, Hengchi Yu, Yulin Gu, Chifa Ma, Chenfei Li, Zimo Pan, Mingxia Yuan","doi":"10.1111/dom.70152","DOIUrl":"https://doi.org/10.1111/dom.70152","url":null,"abstract":"<p><strong>Aim: </strong>Most randomized controlled trials (RCTs) of bariatric surgery have a small size, a limited type of surgical procedure, and follow-up duration. Our aim was to compare bariatric surgery with medical management in patients with type 2 diabetes mellitus (T2DM) based on a meta-analysis of RCTs.</p><p><strong>Materials and methods: </strong>PubMed/Medline, Embase, and the Cochrane Central Register of Controlled Trials were searched for studies published before February 28, 2025. We included RCTs comparing bariatric surgery with medical management in T2DM patients with follow-up ≥1 year. The outcomes of interest were diabetes remission, diabetic microvascular complications, and diabetic macrovascular complications. The criterion of diabetes remission was prespecified in clinical trials' protocols or defined as HbA1c <6.5% measured at least 3 months after cessation of glucose-lowering pharmacotherapy.</p><p><strong>Results: </strong>At 1 year follow-up, 53.1% of patients in the bariatric surgery group achieved diabetes remission, compared to only 5.4% in the medical management group (risk ratio [RR] = 8.26; 95% confidence intervals [CI], 4.69-14.56; p < 0.001). The superiority of bariatric surgery in diabetes remission remained significant at 2 years (RR = 7.42), 3 years (RR = 16.97), and even ≥5 years (RR = 4.26). Bariatric surgery was associated with a significantly reduced risk of diabetic microvascular events compared to medical management (RR = 0.42, 95% CI 0.18-0.97, p = 0.04), while its association with macrovascular events was not statistically significant (RR = 1.09; 95% CI, 0.70-1.70; p = 0.71). Considering the specific microvascular events, bariatric surgery was significantly associated with the reduced incidence of albuminuria (RR = 0.37, 95% CI 0.16-0.81, p = 0.01), but not with diabetic retinopathy.</p><p><strong>Conclusion: </strong>Bariatric surgery seems to be superior to medical management for diabetes remission and improving diabetic microvascular complications in patients with T2DM. However, bariatric surgery and medical management show similar effects on diabetic macrovascular complications.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145129673","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness of oral semaglutide versus empagliflozin for the management of type 2 diabetes. PIONEER-2 trial emulation with real-world data.","authors":"Gian Paolo Fadini, Enrico Longato, Sara Poletto, Andrea Giaccari, Mariangela Ghiani, Marco Strazzabosco, Maddalena Trombetta, Giuseppe Penno, Angelo Avogaro, Anna Solini, Agostino Consoli","doi":"10.1111/dom.70151","DOIUrl":"https://doi.org/10.1111/dom.70151","url":null,"abstract":"<p><strong>Background and aims: </strong>Oral semaglutide and empagliflozin are commonly used for the management of type 2 diabetes (T2D), but head-to-head comparisons in real-world settings are limited. We aimed to emulate the PIONEER-2 trial using electronic health records to compare the effectiveness and persistence of oral semaglutide versus empagliflozin.</p><p><strong>Methods: </strong>This was a retrospective multicentre study using electronic health records from Italian diabetes clinics. New users of oral semaglutide or empagliflozin were matched 1:2 and followed for up to 18 months. The primary outcome was HbA1c change; secondary outcomes included weight change and treatment persistence. Analyses used mixed models for repeated measures under both treatment policy and trial product estimands.</p><p><strong>Results: </strong>After matching, we included new users of oral semaglutide (n = 105) or empagliflozin (n = 207). Mean age was 65 years, diabetes duration 10 years, baseline HbA1c 7.6%, BMI 29 kg/m², and 94% were on metformin. Only 28.6% of new users of oral semaglutide reached the 14 mg dose and 31.4% of empagliflozin new users reached the 25 mg dose. HbA1c reduction was significantly greater with oral semaglutide than with empagliflozin (mean difference - 0.35%, p <0.001). Weight loss over time was similar, with oral semaglutide showing a modest advantage at 18 months among persistent patients. Persistence was lower for semaglutide (HR for discontinuation 1.47, p = 0.007).</p><p><strong>Conclusions: </strong>Under routine care, new users of oral semaglutide achieved better glycaemic control compared with empagliflozin new users, with similar weight loss but lower treatment persistence. These findings support the results of PIONEER-2 and its transferability to clinical practice.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145129718","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The impact of semaglutide on peri-operative cardiovascular outcomes in diabetes.","authors":"Fabio Castrillon, Brooke Carter, Andrew McClure, Blayne Welk, Kristin K Clemens","doi":"10.1111/dom.70145","DOIUrl":"https://doi.org/10.1111/dom.70145","url":null,"abstract":"","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145129728","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Genetic evidence for repurposing GLP-1 receptor agonists in chronic kidney disease and IgA nephropathy: Metabolic and anti-inflammatory pathways beyond glycaemic control.","authors":"Xueying Yang, Wenhao Tang, Han Chan, Mo Wang, Haiping Yang, Qiu Li","doi":"10.1111/dom.70144","DOIUrl":"https://doi.org/10.1111/dom.70144","url":null,"abstract":"<p><strong>Aims: </strong>Despite observational links between glucagon-like peptide-1 receptor agonists (GLP-1RAs) and kidney benefits, causal mechanisms remain unclear. This study aims to dissect genetic causality and mediation pathways underlying the effects of GLP-1RAs on chronic kidney disease (CKD) and related renal outcomes.</p><p><strong>Materials and methods: </strong>Using large-scale Genome - Wide Association Study (GWAS) data, we applied two-sample Mendelian randomisation (MR) to estimate the causal effects of GLP-1RAs on CKD, estimated glomerular filtration rate (eGFR) and subtypes (IgA nephropathy, membranous nephropathy, nephrotic syndrome and chronic glomerulonephritis), with sensitivity analyses. The glycaemic markers (glycated haemoglobin [HbA1c] and blood glucose), type 2 diabetes mellitus (T2DM) and diabetic nephropathy (DN) served as positive controls. Mediation MR assessed body mass index (BMI), lipids, glycaemic markers and inflammatory proteins. Data were sourced from MRC Integrative Epidemiology Unit Open Genome - Wide Association Studies OpenGWAS, FinnGen, GWAS Catalogue and cohort-specific studies.</p><p><strong>Results: </strong>Positive control analyses revealed that genetically predicted GLP-1R activation was associated with reduced levels of HbA1c (p = 4.93E-15) and blood glucose (p = 9.73E-5), as well as a decreased risk of T2DM (p = 2.45E-4) and DN (p = 6.35E-4), fully validating the reliability of the genetic instruments. Genetic proxies for GLP-1R activation lowered risks of CKD (odds ratio [OR] = 0.83, p = 9.22E-9), immunoglobulin A nephropathy (IgAN) (OR = 0.70, p = 2.11E-3) and kidney function preservation (β = 0.01, p = 9.11E-3), but showed null effects on other CKD subtypes. Mediation analyses indicated that fibroblast growth factor 23 (FGF23) suppression mediated 26.57% of the effect on eGFR and 13.50% of CKD protection, whereas metabolic traits (BMI: 2.08% for CKD, 5.51% for eGFR; high-density lipoprotein: 0.79% for CKD, 2.34% for eGFR; HbA1c: 8.25% for eGFR) partially explained the benefits on CKD and eGFR. Only BMI exhibited a mediation effect on IgAN. Sensitivity analyses confirmed minimal pleiotropy.</p><p><strong>Conclusions: </strong>This study provides robust genetic evidence for repurposing GLP-1RAs in CKD and IgAN through anti-inflammatory (FGF23) and metabolic pathways, extending their utility beyond glucose control. While European ancestry data limit generalisability, our framework prioritises FGF23 and metabolic modulation as key targets for clinical trials in renal protection.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145135987","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"GlucoNet-MM: A multimodal attention-based multi-task learning framework with decision transformer for personalised and explainable blood glucose forecasting.","authors":"Sarmad Maqsood, Muhammad Abdullah Sarwar, Egle Belousovienė, Rytis Maskeliūnas","doi":"10.1111/dom.70147","DOIUrl":"https://doi.org/10.1111/dom.70147","url":null,"abstract":"<p><strong>Aims: </strong>Accurate and personalized blood glucose prediction is critical for proactive diabetes management. Conventional machine learning (ML) models often struggle to generalize across patients due to individual variability, nonlinear glycemic dynamics, and sparse multimodal input data. This study aims to develop an advanced, interpretable deep learning (DL) framework for patient-specific, policy-aware blood glucose forecasting.</p><p><strong>Materials and methods: </strong>We propose GlucoNet-MM, a novel multimodal DL framework that combines attention-based multi-task learning (MTL) with a Decision Transformer (DT), a reinforcement learning paradigm that frames policy learning as sequence modeling. The model integrates heterogeneous physiological and behavioral data, continuous glucose monitoring (CGM), insulin dosage, carbohydrate intake, and physical activity, to capture complex temporal dependencies. The MTL backbone learns shared representations across multiple prediction horizons, while the DT module conditions future glucose predictions on desired glycemic outcomes. Temporal attention visualizations and integrated gradient-based attribution methods are used to provide interpretability, and Monte Carlo dropout is employed for uncertainty quantification.</p><p><strong>Results: </strong>GlucoNet-MM was evaluated on two publicly available datasets, BrisT1D and OhioT1DM. The model achieved R² scores of 0.94 and 0.96 and mean absolute error (MAE) values of 0.031 and 0.027, respectively. These results outperform single-modality and conventional non-adaptive baseline models, demonstrating superior predictive accuracy and generalizability.</p><p><strong>Conclusion: </strong>GlucoNet-MM represents a promising step toward intelligent, personalized clinical decision support for diabetes care. Its multimodal design, policy-aware forecasting, and interpretability features enhance both prediction accuracy and clinical trust, enabling proactive glycemic management tailored to individual patient needs.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145111551","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and safety of Efsubaglutide Alfa in \"overrun\" patients in the SUPER2 trial: A post-hoc analysis for comprehensive evaluation.","authors":"Weiping Jia, Fan Jiang, Yulong Xu, Yiming Li, Yuqian Bao, Qinghua Wang","doi":"10.1111/dom.70112","DOIUrl":"https://doi.org/10.1111/dom.70112","url":null,"abstract":"<p><strong>Aims: </strong>Efsubaglutide Alfa is a novel, long-acting, once-weekly GLP-1 receptor agonist. In the pivotal phase 2b/3 SUPER2 trial, Efsubaglutide Alfa 3 mg plus metformin showed significant efficacy and favourable safety in patients with type 2 diabetes (T2D) inadequately controlled on metformin. This post-hoc analysis evaluated the 1 mg dose.</p><p><strong>Materials and methods: </strong>In phase 2b, patients with T2D on metformin were randomized (1:1:1) to once-weekly Efsubaglutide Alfa 1 mg, 3 mg, or placebo for 12 weeks. After interim analysis, 3 mg was selected as the phase 3 dose. However, 155 patients already randomized (the \"overrun\" cohort) completed 24 weeks of double-blind treatment with 1 mg, then entered 28 weeks of open-label 3 mg and 4 weeks of follow-up. This analysis focused on the 1 mg cohort. The primary endpoint was change in HbA1c at week 24; secondary endpoints included fasting plasma glucose (FPG), body weight, HbA1c <7.0%, and subgroup analyses.</p><p><strong>Results: </strong>At week 24, HbA1c decreased by -1.69% (95% CI -1.91 to -1.47) with Efsubaglutide Alfa 1 mg versus -0.74% (-0.96 to -0.52) with placebo, a placebo-corrected difference of -0.95% (95% CI -1.25 to -0.65; p < 0.0001). FPG decreased by -2.09 mmol/L versus -0.50 mmol/L with placebo (difference - 1.59 mmol/L; p < 0.001). Body weight reduction was modest and not significant (-2.8% vs. -1.3%; LSM -0.72 kg; p = 0.137). HbA1c <7.0% was achieved by 56.3% versus 11.1% with placebo (p < 0.0001; odds ratio 8.3). Gastrointestinal adverse events were most common, generally mild and transient, and no drug-related serious events occurred.</p><p><strong>Conclusions: </strong>Efsubaglutide Alfa 1 mg provided clinically meaningful glucose lowering with good tolerability but without significant weight loss. These results support a lower-dose strategy for elderly or frail patients, those with low BMI, or individuals sensitive to gastrointestinal effects, and as a possible lead-in step before escalation. Confirmatory trials are warranted to establish long-term outcomes.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145111606","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Unveiling urinary diagnostic biomarkers for diabetic kidney disease using metabolomics and machine learning approaches.","authors":"Yuan Sun, Haiying Li, Xi Yan, Guanwei Ma, Hongbo Yang, Yikun Zhu, Jiancheng Li, Wei Lu, Man Zhan, Juan Yuan, Zhiyuan Liang, Liming Shen, Yongdong Zou","doi":"10.1111/dom.70138","DOIUrl":"https://doi.org/10.1111/dom.70138","url":null,"abstract":"<p><strong>Aims: </strong>Diabetic kidney disease (DKD) is a specific complication of diabetes that poses a major challenge to global public health. However, clinical detection of DKD still has notable limitations. This study aimed to identify potential biomarkers and explore the underlying mechanisms of DKD.</p><p><strong>Materials and methods: </strong>Urine samples were collected from patients with type 2 diabetes mellitus and healthy subjects. Changes in urine metabolic profiles were analysed via liquid chromatography-tandem mass spectrometry combined with a machine learning approach.</p><p><strong>Results: </strong>Metabolomics revealed characteristic metabolite alterations at different stages of DKD progression, and pathway enrichment analysis revealed significant changes in pathways such as biotin metabolism and taurine and hypotaurine metabolism, among which biotin and taurine are the key regulatory molecules of these pathways. Combined screening with two machine learning algorithms finally identified five differentially expressed metabolites: hypoxanthine, N-acetyl-DL-histidine, cortisol, tetrahydrobiopterin and L-kynurenine. Correlation analysis coupled with receiver operating characteristic curve validation showed these seven biomarkers were significantly correlated with clinical indicators (urinary albumin creatinine ratio, serum creatinine) and had early diagnostic value. Notably, multiple reaction monitoring validation revealed taurine and hypoxanthine expression exhibited DKD stage-dependent characteristics.</p><p><strong>Conclusion: </strong>This study initially identified seven DKD biomarkers with excellent diagnostic performance and further clarified their potential role in mediating DKD progression via mechanisms involving biotin metabolism, taurine and hypotaurine metabolism and steroid hormone biosynthesis. These findings provide important insights for the early precise diagnosis and mechanistic exploration of DKD.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145111620","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reply to \"A comment on 'Metformin in the Diabetes Prevention Program 3-year trial: The cost-effectiveness that never was'\".","authors":"Brian Eric Rittenhouse, Sultan Alolayan, Alissa R Segal, Tewodros Eguale","doi":"10.1111/dom.70149","DOIUrl":"https://doi.org/10.1111/dom.70149","url":null,"abstract":"","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145084646","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimizing cardiovascular health with a type 2 diabetes remission program: Ultraprocessed food-intake reduction, Mediterranean diet, chrononutrition and physical training-The DIABEPIC-2 pilot study.","authors":"Valérie Dionne, Josep Iglesies-Grau, Élise Latour, Florent Besnier, Christine Gagnon, Mathieu Gayda, Véronique Pelletier, Shaun Selcer, Tudor Vrinceanu, Amélie Debray, Anne-Julie Tessier, Martin Juneau, Anil Nigam, Philippe L L'Allier, Louis Bherer","doi":"10.1111/dom.70142","DOIUrl":"https://doi.org/10.1111/dom.70142","url":null,"abstract":"<p><strong>Aims: </strong>The possibility of type 2 diabetes (T2D) remission following very-low caloric restriction has been demonstrated. However, the feasibility of T2D remission following other health behavioural interventions remains to be explored.</p><p><strong>Materials and methods: </strong>The DIABEPIC-2 pilot study assessed the feasibility of a 6-month programme based on ultra-processed food intake reduction, a Mediterranean diet, and physical training. Also, a randomised 2:1 proportion of participants added intermittent fasting (IF) in the last 3 months. The study explored the T2D remission rate and its impact on cardiometabolic and anthropometric parameters, cardiorespiratory fitness, and quality of food matrix.</p><p><strong>Results: </strong>Feasibility was demonstrated with a recruitment rate of 6.4 participants/month, 34 participants (81%) who completed the programme, with an 87% attendance rate (63.6 ± 9.2 years old, initial mean HbA1c of 6.7 ± 0.7%, mean T2D duration of 7.4 ± 6.7 years). At 6 months, participants had a mean weight loss of -6.8 kg (-9.3 to -4.4, p < 0.001), and 13 participants out of 34 (38%) achieved T2D remission. Overall, participants significantly improved cardiometabolic health and anthropometric parameters, cardiorespiratory fitness, and food matrix quality. Participants randomised to the IF add-on intervention group did not show significant additional improvement.</p><p><strong>Conclusion: </strong>The DIABEPIC-2 program enabled a significant proportion of participants to achieve T2D remission and to improve their cardiovascular health; therefore, it would be relevant to confirm these results. The recruitment and visit completion rates observed in this pilot study further demonstrate its feasibility, supporting the rationale for conducting a larger randomized clinical trial.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145084665","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}