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

T2DM (Type 2 Diabetes Mellitus) Clinical Trial

Official title:

The Influence of AMPK Subunit Alpha (PRKAA2) Genetic Polymorphisms With Susceptibility to Chinese Type 2 Diabetes Mellitus and Diabetic Nephropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03155087
• Other study ID #: 2016ys5
• Status: Completed
• Phase: N/A
• First received: May 11, 2017
• Last updated: May 15, 2017
• Start date: June 2013
• Est. completion date: December 2015

Study information

• Verified date: May 2017
• Source: People's Hospital of Zhengzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Nephropathies
• Disease Susceptibility
• Kidney Diseases
• T2DM (Type 2 Diabetes Mellitus)

Intervention

Drug:
• Metformin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
People's Hospital of Zhengzhou University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Jan 2014-Dec 2015
Secondary	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.	Jan 2014-Dec 2015