Evidence map›Paper›PMID 41062131›Full record

ArticleBMJ open2025

Intervention effects of optimised carbohydrate diet in patients with type 2 diabetes: study protocol for a randomised controlled crossover trial.

Yuwei Lu, Ruiqi Zhang, Jingyi Yang, Dan Liu, Qian Wu, Xiaoxue Long, Di Cheng, Jingyi Guo, Qian Li, Ying Zhang and 9 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06936657 (Intervention Effects of Optimized Carbohydrate Diet in Patients With Type 2 Diabetes), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06936657 nanot yet recruitingnot on this map

Intervention Effects of Optimized Carbohydrate Diet in Patients With Type 2 Diabetes

TypeinterventionalSponsorShanghai 6th People's HospitalRan2025 to 2027Enrolled150ConditionsType 2 Diabetes Mellitus (T2DM)Armsoptimized carbohydrate diet, conventional diabetes diet
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Yuwei Lu *State Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.ORCID http://orcid.org/0000-0002-4701-9273
Ruiqi Zhang *State Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.ORCID http://orcid.org/0009-0000-8620-8707
Jingyi Yang *State Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.ORCID http://orcid.org/0009-0002-8578-7617
Dan LiuState Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Qian WuState Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Xiaoxue LongState Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Di ChengState Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.ORCID http://orcid.org/0000-0001-9388-376X
Jingyi GuoClinical Research Center, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Qian LiState Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.ORCID http://orcid.org/0009-0009-6425-2964
Ying ZhangState Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.ORCID http://orcid.org/0000-0003-3288-0041
Piao KangState Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.ORCID http://orcid.org/0009-0003-4157-3446
Qinyi WangState Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Xiaojing GaoShanghai Clinical Research and Trial Center, School of Life Science and Technology, ShanghaiTech University, Shanghai, China.
Rong ZengShanghai Clinical Research and Trial Center, School of Life Science and Technology, ShanghaiTech University, Shanghai, China.
Mingliang ZhangState Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Qichen FangState Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Weiping JiaState Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.ORCID http://orcid.org/0000-0002-6244-2168
Yueqiong NiState Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China huarting99@sjtu.edu.cn bernard_ni@sjtu.edu.cn.ORCID http://orcid.org/0000-0003-1285-7354
Huating LiState Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China huarting99@sjtu.edu.cn bernard_ni@sjtu.edu.cn.ORCID http://orcid.org/0000-0003-0526-5545

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDietary intervention is fundamental for the management of type 2 diabetes (T2D), playing a crucial role in stabilising blood glucose levels and improving quality of life. As the major contributor to daily energy intake, the quality of carbohydrates can directly influence the glycaemic stability. Therefore, we aim to explore whether adjusting and optimising the composition of dietary carbohydrates, specifically starch, can provide multiple metabolic benefits for patients with T2D. METHODS AND ANALYSIS: This multicentre randomised crossover clinical trial will include 150 participants with T2D. Participants will be assigned to either a conventional diet (CD) following the guidelines for T2D or an optimised carbohydrate diet (OCD) focused on increasing resistant starch intake to 40 g/day and decreasing rapidly digestible starch intake for 12 weeks. This will be followed by a 6-week wash-out period, after which participants will crossover to the alternate diet with equal energy and consistent energy proportion of the three macronutrients for another 12 weeks. The primary outcome is the difference in the change of postprandial glycaemia (changes in the average incremental area under the blood glucose curve (iAUC)) induced by OCD and CD interventions. Secondary outcomes include changes in other glucose and lipid metabolism-related parameters and cognitive function, as well as psychological, behavioural and physiological factors. Exploratory outcomes include changes in the iAUCs for each of the three meals, appetite-related hormone levels, degree of hepatic steatosis, serum cytokines, immune functions and multiomics parameters. ETHICS AND DISSEMINATION: The protocol has received approval from the Ethics Committee of Shanghai Sixth People's Hospital (Approval No. 2025-018; Protocol V.4.1, 20250112) and has been registered with the ClinicalTrials.gov Registry. The findings will be disseminated through peer-reviewed journal publications, conference presentations and media releases. TRIAL REGISTRATION NUMBER: NCT06936657.

Indexed as

Diabetes Mellitus, Type 2Dietary CarbohydratesAdultBlood GlucoseCross-Over StudiesEnergy IntakeFemaleHumansMaleMiddle AgedMulticenter Studies as TopicPostprandial PeriodRandomized Controlled Trials as TopicBlood GlucoseDietary CarbohydratesClinical TrialDiabetes & endocrinologyDiabetes Mellitus, Type 2

Identifiers

PMID41062131
PMCPMC13059923

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.