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Genetics of Type 1 Diabetes in Chinese Adolescents and Youth

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ClinicalTrials.gov Identifier: NCT01938365
Recruitment Status : Unknown
Verified November 2013 by Guang Ning, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : September 10, 2013
Last Update Posted : November 13, 2013
Sponsor:
Information provided by (Responsible Party):
Guang Ning, Shanghai Jiao Tong University School of Medicine

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.

Condition or disease
Diabetes Mellitus

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.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Cohort Study of Clinical Characteristics and Genetic Susceptibility of Type 1 Diabetes in Chinese Adolescents and Youth
Study Start Date : January 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Group/Cohort
Diabetes
Normal glucose regulation



Primary Outcome Measures :
  1. Deterioration of pancreatic islet function [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Insulin dosage, HbA1c levels and evaluation of chronic complications [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
Whole blood,fasting serum and stool


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938365


Locations
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China, Shanghai
Ruijin hospital, Shanghai Jiao-Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Guang Ning, Professor    8621-64370045 ext 665344    feifei1116@hotmail.com   
Principal Investigator: Guang Ning, Professor         
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine

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Responsible Party: Guang Ning, Professor, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01938365     History of Changes
Other Study ID Numbers: CCEMD020
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases