Diabetes Mellitus, Type 2NCT03194100
Serum METRNL Concentration in Type 2 Diabetes
An observational study of Diabetes Mellitus, Type 2, run by Chungnam National University Hospital.
Trial summary
The investigators measured serum METRNL levels in newly diagnosed patients with type 2 diabetes (T2DM) compared with normal glucose tolerance or prediabetes and explored the correlations between its serum levels and various metabolic parameters Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 30 Nov 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Oral glucose tolerance test (OGTT) was performed in all of the included participants. The participants were divided into three groups according to the American Diabetes Association criteria; normal glucose tolerance, prediabetes and diabetes mellitus.
Who may be able to join
- Subjects who have not been diagnosed diabetes mellitus
Who cannot join
- Person with diabetes who were treated with oral hypoglycemic agent or insulin
- Individuals with type 1 diabetes, gestational diabetes, active hepatitis/liver cirrhosis, chronic renal failure on hemodialysis, congestive heart failure, or other known major disease
About this study
Official title: Comparison of Serum METRNL Concentration Between Type 2 Diabetes and Normal Glucose Tolerance
The investigators measured serum METRNL levels in newly diagnosed patients with type 2 diabetes (T2DM) compared with normal glucose tolerance or prediabetes and explored the correlations between its serum levels and various metabolic parameters
- Conditions
- Diabetes Mellitus, Type 2
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Mellitus | Not described | |
| Prediabetes | Not described | |
| Normal glucose tolerance | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum METRNL concentration
Measured: on the 1 day of oral glucose tolerance test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start1 Jan 2014
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chungnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bon Jeong Ku, Chungnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194100
- Sponsor's protocol ID
- METRNL
- Status last verified
- Jun 2017
- First submitted
- 18 Jun 2017
- Last updated
- 21 Jun 2017
- 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 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Serum METRNL Concentration Between Type 2 Diabetes and Normal Glucose Tolerance
- ClinicalTrials.gov ID
- NCT03194100
- Acronym / sponsor ID
- METRNL
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Chungnam National University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 21 Jun 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.
The investigators measured serum METRNL levels in newly diagnosed patients with type 2 diabetes (T2DM) compared with normal glucose tolerance or prediabetes and explored the correlations between its serum levels and various metabolic parameters
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diabetes Mellitus | – | – |
| Prediabetes | – | – |
| Normal glucose tolerance | – | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Oral glucose tolerance test (OGTT) was performed in all of the included participants. The participants were divided into three groups according to the American Diabetes Association criteria; normal glucose tolerance, prediabetes and diabetes mellitus.
Key inclusion criteria (1 listed)
- Subjects who have not been diagnosed diabetes mellitus
Key exclusion criteria (2 listed)
- Person with diabetes who were treated with oral hypoglycemic agent or insulin
- Individuals with type 1 diabetes, gestational diabetes, active hepatitis/liver cirrhosis, chronic renal failure on hemodialysis, congestive heart failure, or other known major disease
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
serum METRNL concentration
Time frame: on the 1 day of oral glucose tolerance test
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 21 Jun 2017.
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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 Diabetes Mellitus, Type 2, run by Chungnam National University 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 1 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 21 Jun 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?
serum METRNL concentration (time frame: on the 1 day of oral glucose tolerance test). 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 21 Jun 2017.