NCT04529590

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,004

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

29 days

First QC Date

August 24, 2020

Last Update Submit

January 30, 2024

Conditions

Diabetes

Keywords

130-139/80-89 mmHgall-cause mortalitycardiovascular mortalityglucose metabolismChinese

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.).

    24 months

Secondary Outcomes (2)

  • Rate of major cardiovascular event composite endpoint

    24 months

  • Rate of all-cause death

    24 months

Study Arms (2)

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.

Patients without cardiovascular events after 18 years

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

Eligibility Criteria

Age18 Years - 76 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • aged from 18-76 years old
  • lived in Shanghai Pingliang community for 20 years
  • all participants' blood pressures are at baseline

You may not qualify if:

  • aged \<18 years old or \> 76 years old
  • with second primary malignant diseases. 3. other situations assessed by investigator can disturb quality control of the investigation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

10 ml serum and plasma

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2020

First Posted

August 27, 2020

Study Start

October 1, 2020

Primary Completion

October 30, 2020

Study Completion

September 30, 2023

Last Updated

February 1, 2024

Record last verified: 2024-01

Locations

CN(1)