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

NCT ID: NCT02535299

Last Updated: 2016-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-12-31

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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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insulin

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

Group Type EXPERIMENTAL

Liraglutide

Intervention Type DRUG

GLP-1 analog (1.2mg-1.8mg/day) treatment for 6 months

Metformin

Intervention Type DRUG

Metformin(1500mg-2000mg/day) treatment for 6 months

Interventions

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Liraglutide

GLP-1 analog (1.2mg-1.8mg/day) treatment for 6 months

Intervention Type DRUG

Metformin

Metformin(1500mg-2000mg/day) treatment for 6 months

Intervention Type DRUG

Other Intervention Names

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Victoza Glucophage

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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Third Military Medical University

OTHER

Sponsor Role lead

Responsible Party

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Wu Qinan

the Third Military Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Southwest Hospital of the Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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wu qi nan, doctor

Role: primary

13452867542 ext. +86

chen bing, doctor

Role: backup

68754138 ext. +86

Other Identifiers

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GLP-1

Identifier Type: -

Identifier Source: org_study_id

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