Diabetes MellitusNCT01938365
Genetics of Type 1 Diabetes in Chinese Adolescents and Youth
An observational study of Diabetes Mellitus, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin hospital, Shanghai Jiao-Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Guang Ning, Professor, 8621-64370045 ext. 665344, feifei1116@hotmail.com
Guang Ning, Professor
About this study
Official title: 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:
- To classify diabetes by gene detection in Chinese adolescent and youth.
- To make the relationship between genotype and clinic phenotype in type 1 diabetes.
- To evaluate the effect of environmental factors (intestinal ecosystem)in the pathogenesis of diabetes.
Read the 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.
- Conditions
- Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes | Not described | |
| Normal glucose regulation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deterioration of pancreatic islet function
Measured: 3 years
Secondary outcomes (1)
Insulin dosage, HbA1c levels and evaluation of chronic complications
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startJan 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guang Ning, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938365
- Sponsor's protocol ID
- CCEMD020
- Status last verified
- Nov 2013
- First submitted
- 4 Sep 2013
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33216280
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Clinical Characteristics and Genetic Susceptibility of Type 1 Diabetes in Chinese Adolescents and Youth
- ClinicalTrials.gov ID
- NCT01938365
- Acronym / sponsor ID
- CCEMD020
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 10 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
primary outcome: To explore the genetic susceptibility of diabetes in Chinese adolescent and youth.
secondary outcomes:
- To classify diabetes by gene detection in Chinese adolescent and youth.
- To make the relationship between genotype and clinic phenotype in type 1 diabetes.
- To evaluate the effect of environmental factors (intestinal ecosystem)in the pathogenesis of diabetes.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes | – | – |
| Normal glucose regulation | – | – |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Deterioration of pancreatic islet function
Time frame: 3 years
1 secondary outcome
Insulin dosage, HbA1c levels and evaluation of chronic complications
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
- Derived from this study: PubMed 33216280Gao 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.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruijin hospital, Shanghai Jiao-Tong University School of Medicine
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deterioration of pancreatic islet function (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01938365, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2013.