Precise Treatment of Prediabetes and Stage 1 Hypertension

Completed

• Conditions: Diabetes

• Registration Number: NCT04529590
• Lead Sponsor: Ruijin Hospital

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.

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 Timeline

• Study First Submitted: 2020-08-24
• Study First Submitted QC: 2020-08-24
• Study First Posted: 2020-08-27
• Study Start: 2020-10-01
• Primary Completion: 2020-10-30
• Study Completion: 2023-09-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2004

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of nonfatal stroke	24 months	Stroke can be divided into ischemic stroke, subarachnoid hemorrhage, cerebral parenchymal hemorrhage, other hemorrhage, other types or unknown types.
Rate of heart failure	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.
Rate of nonfatal myocardial infarction	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.
Rate of cardiovascular death	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

Name	Time	Method
Rate of all-cause death	24 months	all-cause death
Rate of major cardiovascular event composite endpoint	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.

Trial Locations

Locations (1)

Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China