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

Phase 4

• Conditions: GLP-1；Metformin；Telomere-telomerase System；Par-4
• Interventions: Drug: Liraglutide; Drug: Metformin

• Registration Number: NCT02535299
• Lead Sponsor: Third Military Medical University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-08-21
• Study First Submitted QC: 2015-08-25
• Study First Posted: 2015-08-28
• Study Start: 2016-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-10
• Last Update Posted: 2016-09-13
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
insulin	Liraglutide	basic insulin treatment：glargine 10-30 units once a day based on the glucose control for 6 months.
insulin	Metformin	basic insulin treatment：glargine 10-30 units once a day based on the glucose control for 6 months.

Primary Outcome Measures

Name	Time	Method
physiological parameter:glycosylated hemoglobin A1c	up to 6 months;	up to 6 months;;HbA1c was measured by a certified hospital laboratory according to established and approved protocols

Secondary Outcome Measures

Name	Time	Method
physiological parameter:the concentration of Par-4	up to 6 months;	up to 6 months;;secretary Par-4 were detected with Par-4 ELISA kit (MBL, USA)
physiological parameter:telomease activity	up to 6 months;	up to 6 months;;Telomerase activity was measured using the TeloTAGGG Telomerase PCR ELISAPLUS kit (Roche Diagnostics, Mannheim, Germany)
physiological parameter:TNF-α	up to 6 months;	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)
physiological parameter:telomere length	up to 6 months;	up to 6 months;;Telomere length was measured via fluorescence in situ hybridization using flow cytometry

Trial Locations

Locations (1)

Southwest Hospital of the Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China