NCT03155087

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2013

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

2 years

First QC Date

May 11, 2017

Last Update Submit

May 15, 2017

Conditions

Keywords

T2DMgenetic polymorphismdiabetic nephropathy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • metformin efficacy----the decrease level of HbA1c

    Jan 2014-Dec 2015

Study Arms (2)

T2DM patients

Metformin dosages ranged from 500 to 2000 mg per day

Drug: Metformin

healthy subjects

the healthy subjects was not intervened

Interventions

T2DM patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetic Nephropathies

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes Complications

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 11, 2017

First Posted

May 16, 2017

Study Start

June 1, 2013

Primary Completion

June 1, 2015

Study Completion

December 1, 2015

Last Updated

May 16, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share