Par-4 and Telomere-telomerase System in Type 2 Diabetes Patients Who Received GLP-1 or Metformin Treatment

Study Overview
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Brief Summary
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Objectives: To investigate the treatment effect between insulin,metformin and Liraglutide; in Type 2 Diabetes in our hospital, in order to investigate the possible mechanism about telomere-telomerase system and Par-4.

Detailed Description
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160 Type 2 diabetes in our hospital will divide into 4 groups: group A (40 healthy volunteers), group B (40 patients who give basal and insulin treatment, group C（40 patients who give basal and Liraglutide treatment),group D（40 patients who give basal and metformin treatment). The age, height, weight, blood glucose, glycosylated hemoglobin A1c（HbA1c）,homeostasis model assessment(HOMA-IR), lipid, blood pressure, course of disease, telomere length,telomerase activity will record respectively. And High-sensitive C-reactive protein (HsCRP), Par-4, GST,SOD,GSH-PX,ATF-6,CHOP,XBP-1 and Tumor necrosis factor-α（TNF-α） will detect as Baseline. After each group's treatment, Change from baseline of all indexes will record, Multifactor logistic regression will be analyzed the correlations between each positive indexes.

Official Title
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The Correlation Between Par-4 and Telomere-telomerase System in the New Dignosised Type 2 Diabetes Patients Who Received GLP-1 Analog or Metformin Treatment

Conditions
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GLP-1；Metformin；Telomere-telomerase System；Par-4

Intervention / Treatment
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* Drug: Liraglutide
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly dignosised type 2 diabetes according to WHO criteria.glycated hemoglobin (HbA1c) was more than 10%; Seronegative for antibodies against insulin, islet cells and glutamic acid decarboxylase (GAD); Exclusion Criteria: Type 1 diabetes mellitus,presence of autoimmune diabetes indicated by antibodies to insulin, islet cells, and GAD； Gestational diabetes; patients with heart, liver, or renal function impairment;presence of severe infections or cerebrovascular disease;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: insulin<br>basic insulin treatment：glargine 10-30 units once a day based on the glucose control for 6 months. | Drug: Liraglutide<br>* GLP-1 analog (1.2mg-1.8mg/day) treatment for 6 months<br>* Other names: Victoza;Drug: Metformin<br>* Metformin(1500mg-2000mg/day) treatment for 6 months<br>* Other names: Glucophage;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physiological parameter:glycosylated hemoglobin A1c | up to 6 months;;HbA1c was measured by a certified hospital laboratory according to established and approved protocols | up to 6 months; | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physiological parameter:the concentration of Par-4 | up to 6 months;;secretary Par-4 were detected with Par-4 ELISA kit (MBL, USA) | up to 6 months; | 
| physiological parameter:telomere length | up to 6 months;;Telomere length was measured via fluorescence in situ hybridization using flow cytometry | up to 6 months; | 
| physiological parameter:telomease activity | up to 6 months;;Telomerase activity was measured using the TeloTAGGG Telomerase PCR ELISAPLUS kit (Roche Diagnostics, Mannheim, Germany) | up to 6 months; | 
| physiological parameter:TNF-α | up to 6 months, TNF-a levels were measured by commercial ELISA kit following the manufacturer's instructions;TNF-a levels were measured by commercial ELISA kit following the manufacturer's instructions;(MBL, USA) | up to 6 months; | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telomere-telomerase, Par-4, GLP-1, metformin