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Precise Treatment of Prediabetes and Stage 1 Hypertension

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Completed

Conditions

Diabetes

Study type

Observational

Funder types

Other

Identifiers

NCT04529590
2018-212

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,004 patients

Sex

All

Ages

18 to 76 years old

Volunteers

No Healthy Volunteers

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.

Trial design

2,004 participants in 2 patient groups

Patients with cardiovascular events after 18 years
Description:
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
Description:
For negative patients' samples will be collected at baseline as negative control.

Trial contacts and locations

1

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Central trial contact

Jingyan Tian; Zhe Chen

Data sourced from clinicaltrials.gov

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