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Epidemiologic studies have revealed a tremendous increase in the prevalence of diabetes and related mortality worldwide. In order to meet all the challenges in the treatment of metabolic diseases in China, the National Metabolic Management Center (MMC) was founded in 2016. The objective of the MMC is to launch a new metabolic disease management model based on the Internet health information platform. It allows the application and evaluation of diabetes treatment strategies at these centers. The proprietary electronic medical database in the MMC will help the dynamic big-data analysis in diabetes epidemiology, prevention, diagnosis, and treatment. It will also provide prospective data support including economic evaluation in management of chronic diseases for the Healthy China 2030 strategy.
Objective
Epidemiologic studies have revealed a tremendous increase in the prevalence of diabetes and related mortality worldwide. The general population-based survey in China in 2010, using the American Diabetes Association (ADA) 2010 criteria, revealed that the prevalence of diabetes and prediabetes in adults was 11.6% and 50.1%, respectively, indicating that China has the highest diabetes prevalence in Asia and largest absolute disease burden of diabetes in the world. Lifestyle changes, aging, and obesity have become the main reasons for this increase in the prevalence of diabetes.
In order to meet all the challenges in the treatment of metabolic diseases in China, the National Metabolic Management Center (MMC) was founded in 2016. With advanced medical equipment and Internet of Things (IoT) technology, the MMC is committed to creating an online and offline integrated solution for diabetes, and for the entire spectrum of metabolic disease, to achieve a more convenient and precise model of care for patients. The MMC is focused on establishing highly efficient diagnosis and treatment, as well as comprehensive disease management both in and out of hospital. All MMCs in China have the same structure in terms of facilities, layout, and databases, as well as the same routine daily operations, aiming to establish a platform with standardized diagnosis and treatment of metabolic diseases and their long-term follow-up. This platform of treatment is called the'One Center, One Stop, and One Standard Model'.
The objective of the MMC is to launch a new metabolic disease management model based on the Internet health information platform. It allows the application and evaluation of diabetes treatment strategies at these centers. The proprietary electronic medical database in the MMC will help the dynamic big-data analysis in diabetes epidemiology, prevention, diagnosis, and treatment. It will also provide prospective data support including economic evaluation in management of chronic diseases for the Healthy China 2030 strategy.
Objective:
Methods: After obtaining informed consent, patients will be invited and initiated with a comprehensive baseline evaluation at each MMC centers. Then patients will be followed by clinical/laboratory visits at MMC every 3-6 month later on according to individualized patient's treatment plans. A repeated comprehensive clinical and laboratory assessment for glycemic and risk factors control, safety, as well as diabetes-specific complications will be scheduled once a year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Patients with diabetes mellitus including: type 1 or type 2 diabetes mellitus, monogenetic diabetes, pancreatogenic diabetes, drug-induced diabetes, other forms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard diabetes management model in each MMC center | Other | Standard diabetes management model in each MMC center |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of all diabetes-related clinical endpoints; including: 1. Macrovascular morbidity | through study completion, up to 20 years | |
| Microvascular morbidity | through study completion, up to 20 years | |
| Mortality | through study completion, up to 20 years | |
| Major infections - pulmonary and non-pulmonary requiring hospitalizations | through study completion, up to 20 years | |
| Heart failure | including hospitalized or treated heart failure, or heart failure death | through study completion, up to 20 years |
| Neuropathy | defined as a composite score by the assessment of positive responses among symptoms (by a careful history), sensory signs, or absent or hypoactive reflexes consistent with a distal symmetrical polyneuropathy, and at least one abnormal nerve conduction | through study completion, up to 20 years |
| All cancers | The occurrence of any of the following cancers: prostate, breast, lung/bronchus, endometrial, colon, gastric, leukemia, lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma, etc | through study completion, up to 20 years |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c (%) | through study completion, up to 20 years | |
| Fasting and postprandial glucose (mmol/L) | through study completion, up to 20 years | |
| Blood pressures (mmHg) |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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All the patients who are seen and treated at each MMC centers, and meet the In-/Ex-clusion Criteria will be included in this study
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guang Ning, MD,PHD | Contact | 008621-64370045 | 671817 | gning@sibs.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Metabolic Management center | Recruiting | Multiple Locations | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30284373 | Background | Zhang Y, Wang W, Ning G. Metabolic Management Center: An innovation project for the management of metabolic diseases and complications in China. J Diabetes. 2019 Jan;11(1):11-13. doi: 10.1111/1753-0407.12847. Epub 2018 Oct 3. No abstract available. | |
| 42271560 | Derived | Jiang Y, Gu L, Ma Y, Qu Y, Wan H, Lv K, Zhu Q, Zhou H, Sun J, Lu F, Li X, Wang Y, Zhou J, Liu K, Wang Y, Shen Y. Abnormal Glycaemic Fluctuations Associated With Early Microvascular Changes in the Retina and Choroid of Nondiabetic Adults. Diabetes Obes Metab. 2026 Jun 10. doi: 10.1111/dom.70973. Online ahead of print. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2022 | Dec 2, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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DNA, Serum, plasma and full blood samples are retained
| through study completion, up to 20 years |
| lipids (mg/dl) | through study completion, up to 20 years |
| Body mass index (BMI) | Body weight (kg) and height (m) will be combined to report BMI in kg/m^2 | through study completion, up to 20 years |
| Visceral fat (cm^2) | through study completion, up to 20 years |
| Health related quality of life | Evaluated with HQoL scales such as Short Form 12 Health Survey Questionnaire | through study completion, up to 20 years |
| Cognitive function | Incidences of all-cause dementia and mild cognitive impairment, cognitive function assessed by cognitive function scale | through study completion, up to 20 years |
| Psychological well being | using physiological parameter, questionnaire | through study completion, up to 20 years |
| Cost-effectiveness | The incremental cost per quality adjusted life year (QALY) gained. QALYs will be measured by the EuroQol-5 Dimensions (EQ-5D) questionnaire | through study completion, up to 20 years |
| 41991218 | Derived | Shi J, Zhao D, Wang J, Wang Y, Dong Q, Hu J, Sha Y, Peng Y, Dai Y, Zheng Q, Xu F, Lan H, Ji B, Li L, Qiu H, Jiang R, Tang R, Qu S, Yang L, Ke T, Li S, Zhao Z, Zhang Y, Wang W; MMC and ChinaMAP Collaborative Group. Sex-specific and BMI-specific associations between visceral fat and diabetic kidney disease in patients with diabetes: a large-scale multicentre prospective cohort study. Lancet Diabetes Endocrinol. 2026 May;14(5):401-411. doi: 10.1016/S2213-8587(26)00001-X. |
| 38131034 | Derived | Mu L, Li C, Zhao W, Li A, Zhao D, Zhang B. Association between Sleep Duration and Left Ventricular Hypertrophy for Patients with Type 2 Diabetes Mellitus. Int J Endocrinol. 2023 Nov 28;2023:5532778. doi: 10.1155/2023/5532778. eCollection 2023. |
| 35784580 | Derived | Li L, Mi Y, Xu M, Ruan L, Sun J, Song Q. Influence of Dietary Salt Intake on T2D Treatment. Front Endocrinol (Lausanne). 2022 Jun 15;13:926143. doi: 10.3389/fendo.2022.926143. eCollection 2022. |
| 33790605 | Derived | Yang X, Lin Y, Xu GD, Chen YS, Zhou Y, Sun J, Li L. Optimal Cut-Off Values of Visceral Fat Area for Predicting Metabolic Syndrome Among Type 2 Diabetes Patients in Ningbo, China. Diabetes Metab Syndr Obes. 2021 Mar 25;14:1375-1383. doi: 10.2147/DMSO.S304164. eCollection 2021. |
| D004700 | Endocrine System Diseases |