China Diabetes Registry by Metabolic Management Center

NCT03811470 | Recruiting

• 1 other identifier: CCEMD-2018-1201
• Study Type: observational
• Target: 1,000,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 1.The purpose of the present study is to establish a multi-center nationwide prospective database of diabetes patients in MMCs, including clinical data, biological samples library so as to explore the epidemiology, genetics, new biomarkers, risk factors, and prognostic methods related to diabetes and its complications, as well as other metabolic diseases.
2. 2.To collect cross-sectional data from patients seen and treated at each MMC centers so as to evaluate: the current status of care of patients with diabetes and its related complications, as well as other risk factors treatment strategies at these centers. Patients'costs and quality of life (QoL) will also be evaluated.
3. 3.To collect the prospective data of patients treated at each MMC centers in order to evaluate the strategies for the achievement of treatment goals, changes in management, control of risk factors, incidence and progression of all-diabetes related clinical endpoints (including mortality), behavioral changes, psychological well being as well as costs and QoL.

Conditions

Type 2 Diabetes Mellitus; Type1 Diabetes Mellitus; Monogenetic Diabetes; Pancreatogenic Diabetes; Drug-Induced Diabetes Mellitus; Other Forms of Diabetes Mellitus

Outcome Measures

Primary Outcomes (7)

• 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

Secondary Outcomes (10)

• HbA1c (%)

  through study completion, up to 20 years

• Fasting and postprandial glucose (mmol/L)

  through study completion, up to 20 years

• Blood pressures (mmHg)

  through study completion, up to 20 years

• lipids (mg/dl)

  through study completion, up to 20 years

• Body mass index (BMI)

  through study completion, up to 20 years

Study Arms (1)

1

Patients with diabetes mellitus including: type 1 or type 2 diabetes mellitus, monogenetic diabetes, pancreatogenic diabetes, drug-induced diabetes, other forms

Other: Standard diabetes management model in each MMC center

Interventions

Standard diabetes management model in each MMC center OTHER

Standard diabetes management model in each MMC center

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age ≥ 18 years old
• Diagnosis of diabetes mellitus based on self-reported history of diagnosed diabetes by clinicians or in line with the current domestic diagnostic criteria for diabetes
• Gender: males and females
• Provide written informed consent
• Satisfactory compliance

You may not qualify if:

• Patients with significantly reduced life expectancy (less than 5 years)
• With Drug abuse
• With AIDS or syphilis or infectious diseases such as viral hepatitis or tuberculosis in active phase at enrollment

Sponsors & Collaborators

• Guang Ning: lead

Study Sites (1)

National Metabolic Management center

Multiple Locations, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 30284373 BACKGROUND

• 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.

  PMID: 38131034 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.

  PMID: 35784580 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.

  PMID: 33790605 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

DNA, Serum, plasma and full blood samples are retained

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Guang Ning, MD,PHD

CONTACT

008621-64370045; gning@sibs.ac.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice-president of Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Chairman of the Chinese National Clinical Research Center for Endocrine and Metabolic Diseases

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: January 22, 2019
• Study Start: May 31, 2017
• Primary Completion (Estimated): May 31, 2037
• Study Completion (Estimated): May 31, 2039
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

CN (1)