Study of Comparison the Treatment Effect Between Gastric Bypass and Exenatide in Type 2 Diabetes

What Was Tested

This registered phase 4 trial tested Exenatide.

Objectives: To investigate the treatment effect between Gastric Bypass and Exenatide in Type 2 Diabetes in their hospital, in order to investigate the possible mechanism of Gastric Bypass and Exenatide.

It had three arms (groups): basal treatment (no intervention), Gastric Bypass (experimental) and Exenatide (experimental).

Basal treatment.

Basal treatment and Gastric Bypass.

Basal treatment and Exenatide.

The registry classes the interventions as drug and procedure.

More on the Plan

Methods: 60 Type 2 diabetes in their hospital will divide into 3 groups: group A (20 patients who give basal treatment), group B (20 patients who give basal and Exenatide treatment, group C（20 patients who give basal and Gastric Bypass treatment).

Left ventricular mass index (LVMI), relative wall thickness (RWT) will calculate and High-sensitive C-reactive protein (HsCRP), adiponectin 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: 60 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: BMI ≥ 35kg/m2, With Type 2 Diabetes;. Between the Ages of 18-60 Years;. Course of Type 2 Diabetes ≤ 5 Years;.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: non-diabetic patients , type 1 diabetes (serum insulin antibodies (ica) or glutamic acid decarboxylase antibodies (gada)-positive autoimmune diabetes), special type of diabetes, gestational diabetes;; patients who had liver or renal failure; severe infections in patients and patients who had cerebrovascular disease.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2008-02 with completion listed for 2016-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Clinical events (time frame: 1 year).

It also tracked 7 secondary outcomes, for example echocardiography, echocardiography, Blood testing, Blood testing, Blood testing and Blood pressure monitoring.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 60 people.

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

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