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AzTrials

Type 2 Diabetes MellitusCDR-MMCNCT03811470

China Diabetes Registry by Metabolic Management Center

An observational study of Type 2 Diabetes Mellitus and Type1 Diabetes Mellitus, run by Guang Ning at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Standard diabetes management model in each MMC center
How many people
1,000,000 participants
Where
1 siteChina
Study dates
31 May 2017to 31 May 2039
How long will I take part?
20 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Main Inclusion Criteria:

  • 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

Main Exclusion Criteria:

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • National Metabolic Management center

    Multiple Locations

    Guang Ning, Professor, 8621-64370045 ext. 671817, gning@sibs.ac.cn

    Guang Ning, Professor

    Recruiting

Other trials in China

About this study

Official title: China Diabetes Registry - a Prospective Cohort Study of Patients With Diabetes in National Metabolic Management Centers in China

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. 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. 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. 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.
Read the detailed description

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:

  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. 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. 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.

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.

Being tested
Standard diabetes management model in each MMC center
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard diabetes management model in each MMC centerOther

    Standard diabetes management model in each MMC center

Study groups in NCT03811470
Study groupRoleWhat they receive
1Patients with diabetes mellitus including: type 1 or type 2 diabetes mellitus, monogenetic diabetes, pancreatogenic diabetes, drug-induced diabetes, other forms
Receives: Other: Standard diabetes management model in each MMC center

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of all diabetes-related clinical endpoints; including: 1. Macrovascular morbidity

    Measured: through study completion, up to 20 years

  2. Microvascular morbidity

    Measured: through study completion, up to 20 years

  3. Mortality

    Measured: through study completion, up to 20 years

  4. Major infections - pulmonary and non-pulmonary requiring hospitalizations

    Measured: through study completion, up to 20 years

  5. Heart failure

    including hospitalized or treated heart failure, or heart failure death

    Measured: through study completion, up to 20 years

  6. 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

    Measured: through study completion, up to 20 years

  7. 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

    Measured: through study completion, up to 20 years

Secondary outcomes (10)
  1. HbA1c (%)

    Measured: through study completion, up to 20 years

  2. Fasting and postprandial glucose (mmol/L)

    Measured: through study completion, up to 20 years

  3. Blood pressures (mmHg)

    Measured: through study completion, up to 20 years

  4. lipids (mg/dl)

    Measured: through study completion, up to 20 years

  5. Body mass index (BMI)

    Body weight (kg) and height (m) will be combined to report BMI in kg/m^2

    Measured: through study completion, up to 20 years

  6. Visceral fat (cm^2)

    Measured: through study completion, up to 20 years

  7. Health related quality of life

    Evaluated with HQoL scales such as Short Form 12 Health Survey Questionnaire

    Measured: through study completion, up to 20 years

  8. Cognitive function

    Incidences of all-cause dementia and mild cognitive impairment, cognitive function assessed by cognitive function scale

    Measured: through study completion, up to 20 years

  9. Psychological well being

    using physiological parameter, questionnaire

    Measured: through study completion, up to 20 years

  10. Cost-effectiveness

    The incremental cost per quality adjusted life year (QALY) gained. QALYs will be measured by the EuroQol-5 Dimensions (EQ-5D) questionnaire

    Measured: through study completion, up to 20 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2019
  2. Study start31 May 2017
  3. Primary completion31 May 2037 (estimated)
  4. Study completion31 May 2039 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000,000 participants (estimated)
Target duration
20 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03811470
Sponsor's protocol ID
CCEMD-2018-1201
Acronym
CDR-MMC
Status last verified
Dec 2024
First submitted
20 Dec 2018
Last updated
5 Dec 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 30284373
  • 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 Sep;28(9):7864-7874. doi: 10.1111/dom.70973. Epub 2026 Jun 10.

    PubMed 42271560
  • 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.

    PubMed 41991218
  • 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.

    PubMed 38131034
  • 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.

    PubMed 35784580
  • 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.

    PubMed 33790605

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes Mellitus and Type1 Diabetes Mellitus, run by Guang Ning at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Guang Ning, MD,PHD (008621-64370045 ext. 671817, gning@sibs.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of all diabetes-related clinical endpoints; including: 1. Macrovascular morbidity (time frame: through study completion, up to 20 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03811470, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.

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