Precise Treatment of Prediabetes and Stage 1 Hypertension

Ruijin Hospital2,004 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

2,004

Conditions

Diabetes

Eligibility

Sex: ALLMin age: 18 YearsMax age: 76 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Rate of nonfatal myocardial infarction

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.

Time frame: 24 months

Rate of nonfatal stroke

Stroke can be divided into ischemic stroke, subarachnoid hemorrhage, cerebral parenchymal hemorrhage, other hemorrhage, other types or unknown types.

Time frame: 24 months

Rate of heart failure

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.

Time frame: 24 months

Rate of cardiovascular death

Cardiovascular death includes stroke, coronary heart disease, heart failure or other forms of cardiovascular disease (such as abdominal aortic aneurysm rupture, arrhythmia, etc.).

Time frame: 24 months

Secondary Outcomes

Rate of major cardiovascular event composite endpoint

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.

Data from ClinicalTrials.gov

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