NCT04966754

Brief Summary

During the study, the resuscitation room, general wards and ICU were installed fixed or mobile acquisition devices in the resuscitation room, the emergency department of Peking Union Medical College Hospital, and the collection platform was set up. Patients with acute diseases (infection, diabetes complications, etc.) caused by metabolic syndrome (obesity, diabetes, etc.) were selected after informed consent. All medical intervention behaviors, relevant medical records and medical outcome records within the collection scope of the device platform were collected prospectively . And regular follow-up, guidance of patients with metabolic syndrome control, while collecting all the lifestyle characteristics of patients, some patients with metabolic cabin research, and observe the relevant medical outcomes. After that, all the collected data were coded, and the influence of all lifestyle and medical behavior interventions on patients' medical outcomes was studied by artificial intelligence method.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 19, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

2.3 years

First QC Date

July 8, 2021

Last Update Submit

July 20, 2021

Conditions

Keywords

metabolicdiabetesobesityinfectioncomplication

Outcome Measures

Primary Outcomes (3)

  • Rate of metabolic complications

    Relapse of acute metabolic disease, stability of biochemical metabolic indexes (such as glycosylated hemoglobin, BMI)

    6 weeks

  • Complication control

    The occurrence of metabolic complications, infection and cardiovascular events

    3 weeks

  • Rate of mortality

    30-day and 90-day mortality. Death due to cardiovascualr complications

    6 months

Secondary Outcomes (2)

  • Total cost of treatment

    3 weeks

  • Quality of life

    6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with metabolic syndrome (obesity, diabetes, etc.) cause acute disease attacks (infection, diabetes complications, etc.).

You may qualify if:

  • Diabetes and / or obesity (BMI\>=28).
  • Emergency room / emergency ward / EICU;
  • Be able to understand and agree the research protocol and sign the informed consent

You may not qualify if:

  • Pregnant women / lactation period;
  • The estimated survival time was less than 1 year;
  • Long term follow-up is not guaranteed;
  • Failure to comply with the protocol or procedure;
  • The collection of medical behavior data can not complete the de privacy or label after de privacy;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Metabolic SyndromeInfectionsObesityDiabetes Mellitus

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsEndocrine System Diseases

Central Study Contacts

Huadong Zhu, MD

CONTACT

Wei Wang, Master

CONTACT

Study Design

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

Study Record Dates

First Submitted

July 8, 2021

First Posted

July 19, 2021

Study Start

August 1, 2021

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

July 27, 2021

Record last verified: 2021-07