Type II Diabetes MellitusNCT03025919
Evaluation of Innovated Screening Tools for Type 2 Diabetes Among Chinese Population(SENSIBLE STUDY I)
An observational study of Type II Diabetes Mellitus, run by Zhongda Hospital at 1 site in China.
Trial summary
Evaluation of using 2h-UG combined with FPG, AGEsP alone or in combination with FPG in diabetes screening in Chinese natural population Read more about this study
- Who is it for?
- Ages 12 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type II Diabetes Mellitus
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Dec 2017
- 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 12 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Natural Chinese population
Who may be able to join
- 20~70 year old urban and rural residents;
- Volunteer to participate in this study and sign informed consent.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Endocrinology, Zhongda Hospital, Institute of Diabetes, Southeast University
Nanjing, Jiangsu
Zilin Sun, +82-025-83262818, sunzilin1963@126.com
Zilin Sun
About this study
Official title: Using 2h-glycosuria Combined With Fasting Plasma Glucose , Advanced Glycation End-product Alone or in Combination With Fasting Plasma Glucose in Diabetes Screening in Chinese Natural Population
Evaluation of using 2h-UG combined with FPG, AGEsP alone or in combination with FPG in diabetes screening in Chinese natural population
Read the detailed description
Using the WHO criteria as the golden standard，drawing the ROC curve of 2h-UG combined with FPG, AGEsP alone or in combination with FPG，calculating the area under the ROC curve.
- Conditions
- Type II Diabetes Mellitus
- Keywords
- Advanced glycation end-product, Glycosuria
- Medical subject headings
- Diabetes Mellitus, Type 2, Glycosuria
What is being measured
The primary outcome is the main question the study is designed to answer.
area under the ROC curve
area under the ROC curve of different method of using 2h-UG combined with FPG, AGEsP alone or in combination with FPG in diabetes screening in Chinese natural population
Measured: 6 months
Secondary outcomes (1)
sensitivity and specificity of screening
Using WHO criteria as golden standard,sensitivity and specificity of using 2h-UG combined with FPG, AGEsP alone or in combination with FPG in diabetes screening in Chinese natural population
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJun 2017 (estimated)
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II Diabetes MellitusStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 20,000 participants (estimated)
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
- NCT03025919
- Sponsor's protocol ID
- 2016YFC1305700s
- Status last verified
- May 2017
- First submitted
- 11 Jan 2017
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
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
- Using 2h-glycosuria Combined With Fasting Plasma Glucose , Advanced Glycation End-product Alone or in Combination With Fasting Plasma Glucose in Diabetes Screening in Chinese Natural Population
- ClinicalTrials.gov ID
- NCT03025919
- Acronym / sponsor ID
- 2016YFC1305700s
- Conditions
- Type II Diabetes Mellitus
- Keywords
- Advanced glycation end-product, Glycosuria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017
- First posted
- 20 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.
Evaluation of using 2h-UG combined with FPG, AGEsP alone or in combination with FPG in diabetes screening in Chinese natural population
Detailed description
Using the WHO criteria as the golden standard，drawing the ROC curve of 2h-UG combined with FPG, AGEsP alone or in combination with FPG，calculating the area under the ROC curve.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Natural Chinese population
Key inclusion criteria (2 listed)
- 20~70 year old urban and rural residents;
- Volunteer to participate in this study and sign 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.
Primary outcome
area under the ROC curve
Time frame: 6 months
area under the ROC curve of different method of using 2h-UG combined with FPG, AGEsP alone or in combination with FPG in diabetes screening in Chinese natural population
1 secondary outcome
sensitivity and specificity of screening
Time frame: 6 months
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.
Related trials for Type II 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
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Department of Endocrinology, Zhongda Hospital, Institute of Diabetes, Southeast University
Nanjing, 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 Type II Diabetes Mellitus, run by Zhongda Hospital 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 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.
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?
area under the ROC curve (time frame: 6 months). 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.