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

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

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.

Study Overview

• Status: Unknown
• Conditions: GLP-1；Metformin；Telomere-telomerase System；Par-4
• Intervention / Treatment: Drug: Liraglutide; Drug: Metformin

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400038
      • Recruiting
      • Southwest Hospital of the Third Military Medical University
      • Contact: wu qi nan, doctor; Phone Number: +86 13452867542; Email: wqn11@126.com
      • Contact: chen bing, doctor; Phone Number: +86 68754138; Email: chenbing3@medmail.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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;

Collaborators and Investigators

• Sponsor: Third Military Medical University

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: August 21, 2015
• First Submitted That Met QC Criteria: August 25, 2015
• First Posted (Estimate): August 28, 2015

Study Record Updates

• Last Update Posted (Estimate): September 13, 2016
• Last Update Submitted That Met QC Criteria: September 10, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: GLP-1; metformin; telomere-telomerase; Par-4
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide; Metformin
• Other Study ID Numbers: GLP-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided