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

Completed

• Conditions: T2DM (Type 2 Diabetes Mellitus)
• Interventions: Drug: Metformin

• Registration Number: NCT03155087
• Lead Sponsor: People's Hospital of Zhengzhou University

Brief 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 influence of STK11polymorphisms on metformin efficacy among Chinese T2DM patients, discuss the association of PRKAA2 polymorphisms between T2DM patients and healthy subjects.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2015-06
• Study Completion: 2015-12
• Status Verified: 2017-05
• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-05-15
• Last Update Submitted: 2017-05-15
• Study First Posted: 2017-05-16
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
T2DM patients	Metformin	Metformin dosages ranged from 500 to 2000 mg per day

Primary Outcome Measures

Name	Time	Method
the incidence of T2DM	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.

Secondary Outcome Measures

Name	Time	Method
metformin efficacy----the decrease level of HbA1c	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.