Genetics of Type 1 Diabetes in Chinese Adolescents and Youth

November 11, 2013 updated by: Guang Ning, Shanghai Jiao Tong University School of Medicine

A Prospective Cohort Study of Clinical Characteristics and Genetic Susceptibility of Type 1 Diabetes in Chinese Adolescents and Youth

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin hospital, Shanghai Jiao-Tong University School of Medicine
        • Contact:
        • Principal Investigator:
          • Guang Ning, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Diabetes
Normal glucose regulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Deterioration of pancreatic islet function
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Insulin dosage, HbA1c levels and evaluation of chronic complications
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

September 4, 2013

First Submitted That Met QC Criteria

September 4, 2013

First Posted (Estimate)

September 10, 2013

Study Record Updates

Last Update Posted (Estimate)

November 13, 2013

Last Update Submitted That Met QC Criteria

November 11, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCEMD020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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