PRKAA2 Genetic Polymorphisms and Its Susceptibility to Chinese Type 2 Diabetes Mellitus and Diabetic Nephropathy

May 15, 2017 updated by: Zhi Li, People's Hospital of Zhengzhou University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

750

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • other significant illness such as cancer, myocardial infarction, stroke, severe liver, and kidney disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
T2DM patients
Metformin dosages ranged from 500 to 2000 mg per day
Drug: Metformin
healthy subjects
the healthy subjects was not intervened

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Jan 2014-Dec 2015

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
metformin efficacy----the decrease level of HbA1c
Time Frame: Jan 2014-Dec 2015
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.
Jan 2014-Dec 2015

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

People's Hospital of Zhengzhou University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

May 11, 2017

First Submitted That Met QC Criteria

May 15, 2017

First Posted (Actual)

May 16, 2017

Study Record Updates

Last Update Posted (Actual)

May 16, 2017

Last Update Submitted That Met QC Criteria

May 15, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016ys5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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