Precise Treatment of Prediabetes and Stage 1 Hypertension

NCT ID: NCT04529590

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2004 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2023-09-30

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.

Conditions

Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Patients without cardiovascular events after 18 years

For negative patients' samples will be collected at baseline as negative control.

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 76 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

2018-212

Identifier Type: -

Identifier Source: org_study_id