Type II DiabetesNCT03024788
Determination of the Optimum Cut-off Value of Type 2 Diabetes Diagnosis Among Chinese Population(SENSIBLE STUDY II)
An observational study of Type II Diabetes, run by Zhongda Hospital.
Trial summary
Study of the correlation between AGEsP and HbA1c and diabetic retinopathy prevalence: determination of cut-off value of AGEsP and HbA1c in type 2 diabetes diagnosis in China Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type II Diabetes
- What is being tested?
- syringe, fundus camera etc
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 6,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2020
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chinese natural population
Who may be able to join
- 20~70 years old;
- Volunteer to participate in this study and signed informed consent.
Who cannot join
- -
About this study
Official title: Determination of Cut-off Value of Advanced Glycation End-product and Glycosylated Haemoglobin in Type 2 Diabetes Diagnosis in China
Study of the correlation between AGEsP and HbA1c and diabetic retinopathy prevalence: determination of cut-off value of AGEsP and HbA1c in type 2 diabetes diagnosis in China
Read the detailed description
To find the cut-off point of AGEsP and HbA1c for diagnosis of diabetes by drawing the logistic regression model between prevalence of retinopathy and AGEsP level and HbA1c level,and find the point where the prevalence of retinopathy changes most rapidly.
- Conditions
- Type II Diabetes
- Being tested
- syringe, fundus camera etc
- Keywords
- Glycosylated haemoglobin, advanced glycation end products
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
syringe, fundus camera etcDevice
Physical examination, fundus examination, blood and urine samples collection
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of retinopathy
the prevalence of retinopathy in different AGEsP and HbA1c levels
Measured: 3 years
Secondary outcomes (1)
incidence of retinopathy
incidence of retinopathy in different AGEsP and HbA1c levels
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 posted19 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJun 2020 (estimated)
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II DiabetesStudies of the same condition, open and under way.
- 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
- 6,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zilin Sun, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024788
- Sponsor's protocol ID
- 2016YFC1305700d
- Status last verified
- May 2017
- First submitted
- 11 Jan 2017
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Cut-off Value of Advanced Glycation End-product and Glycosylated Haemoglobin in Type 2 Diabetes Diagnosis in China
- ClinicalTrials.gov ID
- NCT03024788
- Acronym / sponsor ID
- 2016YFC1305700d
- Conditions
- Type II Diabetes
- Keywords
- Glycosylated haemoglobin, advanced glycation end products
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (actual)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Dec 2020
- First posted
- 19 Jan 2017 (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.
Study of the correlation between AGEsP and HbA1c and diabetic retinopathy prevalence: determination of cut-off value of AGEsP and HbA1c in type 2 diabetes diagnosis in China
Detailed description
To find the cut-off point of AGEsP and HbA1c for diagnosis of diabetes by drawing the logistic regression model between prevalence of retinopathy and AGEsP level and HbA1c level,and find the point where the prevalence of retinopathy changes most rapidly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese natural population
Key inclusion criteria (2 listed)
- 20~70 years old;
- Volunteer to participate in this study and signed informed consent.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| syringe, fundus camera etcPhysical examination, fundus examination, blood and urine samples collection | Device | – |
Primary outcome
prevalence of retinopathy
Time frame: 3 years
the prevalence of retinopathy in different AGEsP and HbA1c levels
1 secondary outcome
incidence of retinopathy
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 8 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Type II Diabetes, run by Zhongda Hospital.
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 2 inclusion and 1 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 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of retinopathy (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2017.