Undiagnosed DiabetesNCT03311802
A Risk Scores for Predicting Prevalence of Diabetes in the LAO Population
An observational study of Undiagnosed Diabetes, run by Chulalongkorn University.
Trial summary
This was a cross-sectional investigation conducted from December 2015 to July 2017, in 15 selected rural villages of 2 districts of Vientiane municipality, Lao PDR. Target population was interested people, both men and women of age range between 30 to 70 years, living in the selected community. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Undiagnosed Diabetes
- How many people
- 1,098 participants
- Where
- No sites listed yet
- Study dates
- 11 Mar 2015to 10 Apr 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: population living in the selected community nearby Vientiane city
Who may be able to join
- of age range between 30 to 70 years, living in the selected community.
Who cannot join
- diagnosed with diabetes and/or using any anti-diabetic drug
About this study
This was a cross-sectional investigation conducted from December 2015 to July 2017, in 15 selected rural villages of 2 districts of Vientiane municipality, Lao PDR. Target population was interested people, both men and women of age range between 30 to 70 years, living in the selected community. Someone diagnosed with diabetes and/or using any anti-diabetic drug was excluded.
The study protocol initiated with the interview on demographic and behavior information with each participant, followed by physical exam and blood pressure measurement.
Fasting glucose were measured.
Read the detailed description
All participants were invited to meet with the researcher.
Demographic data comprises of age, gender, family history of diabetes including parents and sibling, female with history of having baby weighing more than 4 kg, gestational diabetes, and history or current of dyslipidemia (triglycerides >150 mg/dl, LDL-C ≥ 100 mg/dl, HDL-c < 35 mg/dl), and behavior data were smoking habit, physical inactivity (less than 150 min/week or 3 day/week) were collected by interview.
After that each participant was appointed for blood pressure measurement. Body mass index was computed from body weight (kg) divided by body height (m2) using the weight and height scale.
Waist Circumference was measured at the midpoint between the superior border of iliac crest and the lowest rib using measuring tape with the subject in the position of standing relax and in underclothes
Hip circumference is measured at the level of maximal gluteal protrusion
Blood pressure (BP) value was done with the participants, after 5 minutes relaxing, sitting up right with their upper arm positioned at heart level and measured by Omron blood pressure monitor.
Fasting Plasma Glucose was utilized to identify an individual who is normal, has either pre-diabetes or undiagnosed diabetes. Venous blood samples were collected 5 ml from antecubital vein into the test tube
- Conditions
- Undiagnosed Diabetes
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 |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting plasma glucose
overnight fasting blood glucose
Measured: 06.00-09.00 am
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start11 Mar 2015
- Primary completion10 Sep 2016
- Study completion10 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Undiagnosed DiabetesStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,098 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311802
- Sponsor's protocol ID
- risk scores predicting DM
- Status last verified
- Jul 2016
- First submitted
- 12 Oct 2017
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Risk Scores for Predicting Prevalence of Diabetes in the LAO Population
- ClinicalTrials.gov ID
- NCT03311802
- Acronym / sponsor ID
- risk scores predicting DM
- Conditions
- Undiagnosed Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,098 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 11 Mar 2015 (actual)
- Primary completion
- 10 Sep 2016 (actual)
- Study completion
- 10 Apr 2017 (actual)
- First posted
- 17 Oct 2017 (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.
This was a cross-sectional investigation conducted from December 2015 to July 2017, in 15 selected rural villages of 2 districts of Vientiane municipality, Lao PDR. Target population was interested people, both men and women of age range between 30 to 70 years, living in the selected community. Someone diagnosed with diabetes and/or using any anti-diabetic drug was excluded.
The study protocol initiated with the interview on demographic and behavior information with each participant, followed by physical exam and blood pressure measurement.
Fasting glucose were measured.
Detailed description
All participants were invited to meet with the researcher.
Demographic data comprises of age, gender, family history of diabetes including parents and sibling, female with history of having baby weighing more than 4 kg, gestational diabetes, and history or current of dyslipidemia (triglycerides >150 mg/dl, LDL-C ≥ 100 mg/dl, HDL-c < 35 mg/dl), and behavior data were smoking habit, physical inactivity (less than 150 min/week or 3 day/week) were collected by interview.
After that each participant was appointed for blood pressure measurement. Body mass index was computed from body weight (kg) divided by body height (m2) using the weight and height scale.
Waist Circumference was measured at the midpoint between the superior border of iliac crest and the lowest rib using measuring tape with the subject in the position of standing relax and in underclothes
Hip circumference is measured at the level of maximal gluteal protrusion
Blood pressure (BP) value was done with the participants, after 5 minutes relaxing, sitting up right with their upper arm positioned at heart level and measured by Omron blood pressure monitor.
Fasting Plasma Glucose was utilized to identify an individual who is normal, has either pre-diabetes or undiagnosed diabetes. Venous blood samples were collected 5 ml from antecubital vein into the test tube
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- population living in the selected community nearby Vientiane city
Key inclusion criteria (1 listed)
- of age range between 30 to 70 years, living in the selected community.
Key exclusion criteria (1 listed)
- diagnosed with diabetes and/or using any anti-diabetic drug
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
fasting plasma glucose
Time frame: 06.00-09.00 am
overnight fasting blood glucose
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 17 Oct 2017.
- Individual participant dataSharing planned: No
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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 Undiagnosed Diabetes, run by Chulalongkorn University.
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 1 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: finished, as of the sponsor's last update on 17 Oct 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?
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?
fasting plasma glucose (time frame: 06.00-09.00 am). 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 17 Oct 2017.