NCT03692884

Brief Summary

To investigate the risk factors and biomarkers of the microvascular disease,macrovascular disease and neuropathy in patients with diabetes.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
49mo left

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress66%
Jul 2018Jul 2030

Study Start

First participant enrolled

July 1, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed
11.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

12 years

First QC Date

July 17, 2018

Last Update Submit

September 4, 2023

Conditions

Keywords

diabetes mellitusrisk factorsbiomarkerschronic diabetes complications

Outcome Measures

Primary Outcomes (1)

  • The number of patients whoes Diabetic Kidney disease (DKD) is worsen

    Worsen DKD is defined as Urine Albumin Creatinine Ratio (UACR)\> 300 mg/g Cr(twice out of three measures), or 24 hours urinary protein\> 300 mg / 24 h, or double serum creatinine level and at least 200μmol/l (2.26 mg/dl), or require renal replacement therapy, or death due to kidney disease.

    5 years

Secondary Outcomes (6)

  • The number of patients who develop DKD

    5 years

  • The number of patients who develop Diabetic Retinopathy

    5 years

  • The number of patients whoes DR is worsen

    5 years

  • The number of patients who develop Diabetic Neuropathy

    5 years

  • The number of patients who develop Cardiovascular events

    10 years

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The subjects who diagnosed of diabetes mellitus and signed on the informed consent will be enrolled in our study. We intend to enroll hospitalized patients or outpatient with diabetes mellitus from Chongqing Diabetes Centre,Chongqing,China.

You may qualify if:

  • Diagnosis of diabetes mellitus(based on the 1999 WHO diagnostic cretirial);
  • Age younger than 75 years old, gender is not limited;
  • Voluntary to sign on the informed consent.

You may not qualify if:

  • pregnant or breast-feeding women;
  • Patients with chronic disease requiring long-term glucocorticoid therapy;
  • Patients with severe infection (except for diabetic foot) or immune dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qifu Li

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

Related Publications (1)

  • Lv L, Zhou Y, Chen X, Gong L, Wu J, Luo W, Shen Y, Han S, Hu J, Wang Y, Li Q, Wang Z; Chongqing Diabetes Registry Group. Relationship Between the TyG Index and Diabetic Kidney Disease in Patients with Type-2 Diabetes Mellitus. Diabetes Metab Syndr Obes. 2021 Jul 17;14:3299-3306. doi: 10.2147/DMSO.S318255. eCollection 2021.

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma,complete blood cell and urine

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Qifu Li, phD

    First Affiliated Hospital of Chongqing Medical University

    STUDY CHAIR

Central Study Contacts

Zhihong Wang, phD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of endocrinology

Study Record Dates

First Submitted

July 17, 2018

First Posted

October 2, 2018

Study Start

July 1, 2018

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

July 1, 2030

Last Updated

September 6, 2023

Record last verified: 2023-09

Locations