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

What Was Tested

In this phase 4 trial, researchers set out to test Liraglutide.

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

It had 1 arm (groups): insulin (experimental).

The registry classes the interventions as drug.

More on the Plan

160 Type 2 diabetes in their 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.

Who Took Part

Enrollment: 200 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Seronegative for antibodies against insulin, islet cells and glutamic acid decarboxylase (GAD);.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: 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;.

How the Study Was Run

It was run as a single-group and open-label study.

Being open-label, the Liraglutide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2016-06 with completion listed for 2018-12.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: physiological parameter:glycosylated hemoglobin A1c (time frame: up to 6 months;).

It also tracked 4 secondary outcomes, for example physiological parameter:the concentration of Par-4, physiological parameter:telomere length, physiological parameter:telomease activity and physiological parameter:TNF-α.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Liraglutide in 200 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.