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Precise Treatment of Prediabetes and Stage 1 Hypertension

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ClinicalTrials.gov Identifier: NCT04529590
Recruitment Status : Not yet recruiting
First Posted : August 27, 2020
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
Ruijin Hospital

Study Description
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Brief Summary:
To identify the occurrence of diabetes, hypertension, cardiovascular and cerebrovascular events and all-cause death in patients with baseline prediabetes and stage1 hypertension after 18 years follow up. To identify whether one or several metabolites can be used as serum markers to judge the prognosis of patients with prediabetes and stage1 hypertension, and to establish the evaluation model of metabolites for the prognosis.

Condition or disease
Diabetes

Detailed Description:

To identify the occurrence of diabetes, hypertension, cardiovascular and cerebrovascular events and all-cause death in patients with baseline prediabetes and stage1 hypertension after18 years follow up, then explore the role of risk factors. After assessing the association between BP categories and all-cause mortality and cardiovascular mortality, to analyze the risk for all-cause and cardiovascular mortality by blood glucose categories and BP categories combined by using multiple Cox regression analysis. To analyze the corresponding incidence of all-cause mortality per 1,000 person-years for the BP<130/80 mmHg, 130-139/80-89 mmHg, and ≥140/90 mmHg or treated groups respectively after adjusting for age, sex, and other factors. To identify the associations between cardiovascular mortality and BP categories alone or combined with blood glucose categories were consistent with that of all-cause mortality.

To identify relative metabolic molecular biomarker panel detected by mass spectrometry in blood samples correlating with efficacy in prediabetes and stage 1 hypertension among Chinese adults. Compare the plasma metabolic profiles of different groups and the metabolic markers were screened and optimized by multivariate statistical analysis, logistic regression analysis and receiver operating characteristic (ROC) curve analysis.

To determine whether one or several metabolites can be used as serum markers to judge the prognosis of patients with prediabetes and stage1 hypertension, and to establish the evaluation model of metabolites for the prognosis.

Study Design
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Study Type : Observational
Estimated Enrollment : 1600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Precise Treatment of Prediabetes and Stage 1 Hypertension
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Groups and Cohorts
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Group/Cohort
Patients with cardiovascular events after 18 years

Analyzing metabolic markers screened and optimized by multivariate statistical with plasma metabolic profiles from peripheral blood samples of different groups.

Positive patients' samples will be collected at baseline.
Patients without cardiovascular events after 18 years
For negative patients' samples will be collected at baseline as negative control.


Outcome Measures
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Primary Outcome Measures :
  1. nonfatal myocardial infarction [ Time Frame: 24 months ]
    The diagnosis of myocardial infarction includes clinical manifestations (symptoms and signs), measurement of cardiac biomarkers and ECG interpretation; myocardial infarction occurred during surgery / operation and myocardial infarction terminated due to thrombolytic therapy. According to the available data, the outcome evaluator will classify myocardial infarction into three categories: definite, probable and possible. All three types of myocardial infarction were included in the main outcome. Stroke can be judged based on all available data, including symptoms and signs, brain and large vessel imaging, and cardiac examinations such as echocardiography.

  2. nonfatal stroke [ Time Frame: 24 months ]
    Stroke can be divided into ischemic stroke, subarachnoid hemorrhage, cerebral parenchymal hemorrhage, other hemorrhage, other types or unknown types.

  3. heart failure [ Time Frame: 24 months ]
    Heart failure is defined as a clinical syndrome characterized by a variety of symptoms and signs of cardiac decompensation / cardiac pump insufficiency that are hospitalized or require infusion in the emergency room.

  4. cardiovascular death [ Time Frame: 24 months ]
    Cardiovascular death includes stroke, coronary heart disease, heart failure or other forms of cardiovascular disease (such as abdominal aortic aneurysm rupture, arrhythmia, etc.).


Secondary Outcome Measures :
  1. major cardiovascular event composite endpoint [ Time Frame: 24 months ]

    Macrovascular complication outcome: Stroke; Coronary heart disease:, coronary heart disease causes of death;Emergency treatment or hospitalization of heart failure; Cardiovascular death; All-cause death; Cognitive decline; Health-related quality of life.

    Macrovascular complication outcome: Stroke; Coronary heart disease:, coronary heart disease causes of death;Emergency treatment or hospitalization of heart failure; Cardiovascular death; All-cause death; Cognitive decline; Health-related quality of life.


  2. all-cause death [ Time Frame: 24 months ]
    all-cause death


Biospecimen Retention:   Samples Without DNA
10 ml serum and plasma

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Male and female participants ages 18-76 years from the Pingliang community was conducted from November 2002 to January 2003. At baseline, all participants underwent physical examination and were interviewed with standardized questionnaires.
Criteria

Inclusion Criteria:

  1. aged from 18-76 years old
  2. lived in Shanghai Pingliang community for 20 years
  3. all participants' blood pressures are at baseline

Exclusion Criteria:

  1. aged <18 years old or > 76 years old
  2. with second primary malignant diseases. 3. other situations assessed by investigator can disturb quality control of the investigation.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04529590


Contacts
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Contact: Jingyan Tian +86 13774370259 tianjypaper@163.com
Contact: Zhe Chen +86 13918301809 khkychz@163.com

Sponsors and Collaborators
Ruijin Hospital
More Information
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Responsible Party: Ruijin Hospital
ClinicalTrials.gov Identifier: NCT04529590    
Other Study ID Numbers: 2018-212
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ruijin Hospital:
130-139/80-89 mmHg
all-cause mortality
cardiovascular mortality
glucose metabolism
Chinese
Additional relevant MeSH terms:
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Hypertension
Prediabetic State
Vascular Diseases
Cardiovascular Diseases
 Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases