DysglycemiaNCT04004143
Micronutrients and Health in Adult Chinese
An observational study of Dysglycemia and Dyslipidemia, run by Shenzhen Center for Chronic Disease Control.
Trial summary
Adult subjects were recruited from a health examination center. Their fasting blood samples were collected for laboratory analyses of multiple measures including mineral, glucose, lipids, etc. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysglycemia, Dyslipidemia
- How many people
- 1,520 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2013to 31 Dec 2014
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult volunteers visiting a health examination center were randomly recruited with their consent to particiapate the study.
Who may be able to join
- adult volunteer
- Han population
- living in Shenzhen City for > 2 y
Who cannot join
- caught by organic diseases
- in pregnancy
About this study
Adult subjects were recruited from a health examination center. Their fasting blood samples were collected for laboratory analyses of multiple measures including mineral, glucose, lipids, etc.
- Conditions
- Dysglycemia, Dyslipidemia
- Being tested
- No intervention
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention.
| Study group | Role | What they receive |
|---|---|---|
| Cross-sectional | a cross-sectional study. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
circulation concentration of glucose
Glucose (mmol/L) was measured in less than 4 hours after sample collection
Measured: less than 4 hours
circulation concentrations of 4 types of lipids
TG, TC, LDLC, and HDLC (mmol/L) were measured in less than 4 hours after sample collection
Measured: less than 4 hours
circulation concentrations of 5 minerals
all samples were stored at minus 75 degrees Celsius until ready for analysis collectively on a ICP-MS machine for calcium, cobalt, iron, selenium, and zinc (ng/ml)
Measured: less than 3 years
Secondary outcomes (2)
body mass index
body weight (kg) and hight (m) were measured when the volunteers were visiting the health examination center, and the body mass index was calculated later by the formula of body weight/ hight/ hight (kg/m^2).
Measured: less than 1 month
circulation concentration of 25OHD
all samples were stored at minus 75 degrees Celsius until ready for analysis collectively with ELISA kits (nmol/L)
Measured: less than 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start1 Aug 2013
- Primary completion30 Nov 2013
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysglycemiaStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Center for Chronic Disease Control
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University, Shenzhen Qilinshan Sanatorium
- Responsible party
- Principal investigator, Zhou Ji-Chang, Shenzhen Center for Chronic Disease Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004143
- Sponsor's protocol ID
- QLS2014
- Status last verified
- Jun 2019
- First submitted
- 26 Jun 2019
- Last updated
- 1 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micronutrients and Health in Adult Chinese
- ClinicalTrials.gov ID
- NCT04004143
- Acronym / sponsor ID
- QLS2014
- Conditions
- Dysglycemia, Dyslipidemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,520 participants (actual)
- Lead sponsor
- Shenzhen Center for Chronic Disease ControlUniversity, hospital or other
- Collaborators
- Sun Yat-sen University, Shenzhen Qilinshan Sanatorium
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- 30 Nov 2013 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 1 Jul 2019 (actual)
- 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.
Adult subjects were recruited from a health examination center. Their fasting blood samples were collected for laboratory analyses of multiple measures including mineral, glucose, lipids, etc.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cross-sectional | – | Other: No interventiona cross-sectional study. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult volunteers visiting a health examination center were randomly recruited with their consent to particiapate the study.
Key inclusion criteria (3 listed)
- adult volunteer
- Han population
- living in Shenzhen City for > 2 y
Key exclusion criteria (2 listed)
- caught by organic diseases
- in pregnancy
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 |
|---|---|---|
| No interventionNo intervention. | Other | Cross-sectional |
Primary outcome
circulation concentration of glucose
Time frame: less than 4 hours
Glucose (mmol/L) was measured in less than 4 hours after sample collection
circulation concentrations of 4 types of lipids
Time frame: less than 4 hours
TG, TC, LDLC, and HDLC (mmol/L) were measured in less than 4 hours after sample collection
circulation concentrations of 5 minerals
Time frame: less than 3 years
all samples were stored at minus 75 degrees Celsius until ready for analysis collectively on a ICP-MS machine for calcium, cobalt, iron, selenium, and zinc (ng/ml)
2 secondary outcomes
body mass index
Time frame: less than 1 month
circulation concentration of 25OHD
Time frame: less than 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
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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 Dysglycemia and Dyslipidemia, run by Shenzhen Center for Chronic Disease Control.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 1 Jul 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
circulation concentration of glucose (time frame: less than 4 hours). The study lists 3 primary outcomes in all. 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 1 Jul 2019.