Genetics of Type 1 Diabetes in Chinese Adolescents and Youth
A Prospective Cohort Study of Clinical Characteristics and Genetic Susceptibility of Type 1 Diabetes in Chinese Adolescents and Youth
1 other identifier
observational
500
1 country
1
Brief Summary
primary outcome: To explore the genetic susceptibility of diabetes in Chinese adolescent and youth. secondary outcomes:
- 1.To classify diabetes by gene detection in Chinese adolescent and youth.
- 2.To make the relationship between genotype and clinic phenotype in type 1 diabetes.
- 3.To evaluate the effect of environmental factors (intestinal ecosystem)in the pathogenesis of diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2012
Longer than P75 for all trials
1 active site
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
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 4, 2013
CompletedFirst Posted
Study publicly available on registry
September 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedNovember 13, 2013
November 1, 2013
2.9 years
September 4, 2013
November 11, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Deterioration of pancreatic islet function
3 years
Secondary Outcomes (1)
Insulin dosage, HbA1c levels and evaluation of chronic complications
3 years
Study Arms (2)
Diabetes
Normal glucose regulation
Eligibility Criteria
In phase 1:500 patients under diabetic conditions and sex,age-matched NGR(Normal glucose regulation) (2:1) will be enrolled ,all aged from 14-30. In phase 2:200 patients newly diagnosed diabetes (less than 6 month before enrollment )will be genotyped and followed up for 3 years
You may qualify if:
- Age: 14- 30 years old
- Gender: males and females
- Race: han
- Diabetes diagnosed by WHO cafeteria (WHO1999)
- Living in east China area to minimize population stratification
You may not qualify if:
- Secondary diabetes caused by other diseases or drugs
- Moderate to severe liver, kidney dysfunction, i.e. ALT/AST \> 2.5 times the upper limit of normal range or Ccr \< 25ml/min;
- Any other condition or major systemic diseases that the investigator feels would interfere with trial participation or evaluation of results.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ruijin hospital, Shanghai Jiao-Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Related Publications (1)
Gao A, Gu B, Zhang J, Fang C, Su J, Li H, Han R, Ye L, Wang W, Ning G, Wang J, Gu W. Missense Variants in PAX4 Are Associated with Early-Onset Diabetes in Chinese. Diabetes Ther. 2021 Jan;12(1):289-300. doi: 10.1007/s13300-020-00960-5. Epub 2020 Nov 20.
PMID: 33216280DERIVED
Biospecimen
Whole blood,fasting serum and stool
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 4, 2013
First Posted
September 10, 2013
Study Start
January 1, 2012
Primary Completion
December 1, 2014
Study Completion
December 1, 2016
Last Updated
November 13, 2013
Record last verified: 2013-11