Clinical trial NCT04529590: Precise Treatment of Prediabetes and Stage 1 Hypertension
Official title: Precise Treatment of Prediabetes and Stage 1 Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: 130-139/80-89 mmHg
all-cause mortality
cardiovascular mortality
glucose metabolism
Chinese
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 2004
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Rate of nonfatal myocardial infarction
timeFrame: 24 months
measure: Rate of nonfatal stroke
timeFrame: 24 months
measure: Rate of heart failure
timeFrame: 24 months
measure: Rate of cardiovascular death
timeFrame: 24 months
Secondary outcomes:
measure: Rate of major cardiovascular event composite endpoint
timeFrame: 24 months
measure: Rate of all-cause death
timeFrame: 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
References: