Genetics of Type 1 Diabetes in Chinese Adolescents and Youth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Phase 1: Baseline investigation Aims: To explore genetic susceptibility of diabetes in Chinese adolescent and youth.

Subjects and Methods: 500 patients under diabetic conditions and sex,age-matched NGR Healthy control(2:1) will be enrolled ,all aged from 14-30 years old. A comprehensive examination including questionnaire, anthropometric measurements, biochemical analysis will be performed in each study participant. Diabetes should be diagnosed according to the WHO 1999 criteria,type 1 or type 2 diabetes diagnosed by clinical features recommended by International Society of Pediatric and Adolescent Diabetes ( ISPAD ).

Phase 2: Cohort follow-up Aims : To explore the association of genetic backgrounds and clinical characteristics in different types of diabetes in Chinese adolescent and youth.

Subjects and Methods: To recruit and follow up 200 newly diagnosed and genotyped patients for 3 years. Questionnaire, anthropometric measurements, biochemical analysis performed respectively at baseline,3,6,12,24,36 months after enrollment.

Conditions

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Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetes

No interventions assigned to this group

Normal glucose regulation

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Age: 14- 30 years old
2. Gender: males and females
3. Race: han
4. Diabetes diagnosed by WHO cafeteria (WHO1999)
5. Living in east China area to minimize population stratification

Exclusion Criteria

1. Secondary diabetes caused by other diseases or drugs
2. Moderate to severe liver, kidney dysfunction, i.e. ALT/AST \> 2.5 times the upper limit of normal range or Ccr \< 25ml/min;
3. Any other condition or major systemic diseases that the investigator feels would interfere with trial participation or evaluation of results.

Minimum Eligible Age

14 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Guang Ning

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ruijin hospital, Shanghai Jiao-Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Guang Ning, Professor

Role: primary

References

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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.

Reference Type DERIVED

PMID: 33216280 (View on PubMed)

Other Identifiers

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CCEMD020

Identifier Type: -

Identifier Source: org_study_id