T2DM (Type 2 Diabetes Mellitus)NCT03155087
PRKAA2 Genetic Polymorphisms and Its Susceptibility to Chinese Type 2 Diabetes Mellitus and Diabetic Nephropathy
An observational study of T2DM (Type 2 Diabetes Mellitus), run by People's Hospital of Zhengzhou University.
Trial summary
Metformin is a classical oral antidiabetic drug, often recommended to be the first-choice treatment of type 2 diabetes mellitus (T2DM). Based on the previous research on PRKAA2, STK11 and diabetes, this study aimed to investigate the distributive characteristic of PRKAA2 and STK11 polymorphisms and the potential… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- T2DM (Type 2 Diabetes Mellitus)
- What is being tested?
- Metformin
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Dec 2015
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: the study recruited 500 T2DM patients and 250 healthy subjects who meet the enrollment cirterion from Zhengzhou Central Hospital during the period of July 2013 to December 2015 randomly.
Who may be able to join
- diagnosed with T2DM in keeping with the WHO criteria in 1999 [14], with fasting blood glucose (FBG) ≥ 7.0mmol ⁄ L and ⁄ or postprandial blood glucose (PBG) ≥ 11.1mmol ⁄ L; not using other antidiabetic drugs within the experimental period.
Who cannot join
- other significant illness such as cancer, myocardial infarction, stroke, severe liver, and kidney disease
About this study
Official title: The Influence of AMPK Subunit Alpha (PRKAA2) Genetic Polymorphisms With Susceptibility to Chinese Type 2 Diabetes Mellitus and Diabetic Nephropathy
Metformin is a classical oral antidiabetic drug, often recommended to be the first-choice treatment of type 2 diabetes mellitus (T2DM). Based on the previous research on PRKAA2, STK11 and diabetes, this study aimed to investigate the distributive characteristic of PRKAA2 and STK11 polymorphisms and the potential influence of STK11polymorphisms on metformin efficacy among Chinese T2DM patients, discuss the association of PRKAA2 polymorphisms between T2DM patients and healthy subjects.
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Being tested
- Metformin
- Keywords
- T2DM, genetic polymorphism, diabetic nephropathy
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
| Study group | Role | What they receive |
|---|---|---|
| T2DM patients | Metformin dosages ranged from 500 to 2000 mg per day Receives: Drug: Metformin | |
| healthy subjects | the healthy subjects was not intervened |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of T2DM
people whose fasting plasma glucose ≥7.0 mmol/L and/or postprandial plasma glucose ≥11.1 mmol/L is diagnosed with T2DM.
Measured: Jan 2014-Dec 2015
Secondary outcomes (1)
metformin efficacy----the decrease level of HbA1c
patients whose HbA1c levels is decreased by more than 0.5 % from the baseline is deemed as the response group, while the decrease in HbA1c levels less than 0.5 % from the baseline is deemed as the non-response group.
Measured: Jan 2014-Dec 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study startJun 2013
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for T2DM (Type 2 Diabetes Mellitus)Studies 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
- Retrospective
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- People's Hospital of Zhengzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhi Li, People's Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155087
- Sponsor's protocol ID
- 2016ys5
- Status last verified
- May 2017
- First submitted
- 11 May 2017
- Last updated
- 16 May 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li Q, Li C, Li H, Zeng L, Kang Z, Mao Y, Tang X, Zheng P, He L, Luo F, Li Z. STK11 rs2075604 Polymorphism Is Associated with Metformin Efficacy in Chinese Type 2 Diabetes Mellitus. Int J Endocrinol. 2017;2017:3402808. doi: 10.1155/2017/3402808. Epub 2017 Jul 9.
PubMed 28775741
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of AMPK Subunit Alpha (PRKAA2) Genetic Polymorphisms With Susceptibility to Chinese Type 2 Diabetes Mellitus and Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT03155087
- Acronym / sponsor ID
- 2016ys5
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Keywords
- T2DM, genetic polymorphism, diabetic nephropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- People's Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 May 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.
Metformin is a classical oral antidiabetic drug, often recommended to be the first-choice treatment of type 2 diabetes mellitus (T2DM). Based on the previous research on PRKAA2, STK11 and diabetes, this study aimed to investigate the distributive characteristic of PRKAA2 and STK11 polymorphisms and the potential influence of STK11polymorphisms on metformin efficacy among Chinese T2DM patients, discuss the association of PRKAA2 polymorphisms between T2DM patients and healthy subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T2DM patients | – | Drug: MetforminMetformin dosages ranged from 500 to 2000 mg per day |
| healthy subjects | – | –the healthy subjects was not intervened |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- the study recruited 500 T2DM patients and 250 healthy subjects who meet the enrollment cirterion from Zhengzhou Central Hospital during the period of July 2013 to December 2015 randomly.
Key inclusion criteria (1 listed)
- diagnosed with T2DM in keeping with the WHO criteria in 1999 [14], with fasting blood glucose (FBG) ≥ 7.0mmol ⁄ L and ⁄ or postprandial blood glucose (PBG) ≥ 11.1mmol ⁄ L; not using other antidiabetic drugs within the experimental period.
Key exclusion criteria (1 listed)
- other significant illness such as cancer, myocardial infarction, stroke, severe liver, and kidney disease
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 |
|---|---|---|
| Metformin | Drug | T2DM patients |
Primary outcome
the incidence of T2DM
Time frame: Jan 2014-Dec 2015
people whose fasting plasma glucose ≥7.0 mmol/L and/or postprandial plasma glucose ≥11.1 mmol/L is diagnosed with T2DM.
1 secondary outcome
metformin efficacy----the decrease level of HbA1c
Time frame: Jan 2014-Dec 2015
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 16 May 2017.
- Derived from this study: PubMed 28775741Li Q, Li C, Li H, Zeng L, Kang Z, Mao Y, Tang X, Zheng P, He L, Luo F, Li Z. STK11 rs2075604 Polymorphism Is Associated with Metformin Efficacy in Chinese Type 2 Diabetes Mellitus. Int J Endocrinol. 2017;2017:3402808. doi: 10.1155/2017/3402808. Epub 2017 Jul 9.
- 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 T2DM (Type 2 Diabetes Mellitus), run by People's Hospital of Zhengzhou 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 16 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?
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?
the incidence of T2DM (time frame: Jan 2014-Dec 2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03155087, which also lists 1 linked publication.
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 16 May 2017.