Randomized, double blind, placebo controlled study to investigate efficacy of Helicobacter pylori eradication on type 2 diabetes metabolism.

Randomised, double blind, placebo controlled study to investigate the efficacy of Helicobacter pylori eradication using Esomeprazole, Clarithromycin and Amoxicillin on glucose homeostasis in type 2 diabetes metabolism.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000255280

Enrollment

300

Registered

2009-05-13

Start date

2007-10-24

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Helicobacter pylori (HP) is the most common cause of bacterial chronic infection and is known to influence different metabolic pathways. It has been demonstrated that HP positive type 2 diabetic subjects present a 4-fold increased risk of developing coronary heart disease with respect to HP negative subjects. Starting from these data, we retain that the eradication of HP, at least reducing the inflammatory status, can improve the metabolic assessment in diabetic patients. The aim of this study is to verify the effects of the eradication of HP in diabetic subjects on the main cardiovascular risk factors including insulin resistance, lipid profile, endothelial dysfunction, oxidative stress, inflammatory status and hemocoagulative system.

Interventions

Esomeprazole 20 mg given twice daily + Clarithromycin 500 mg twice daily + Amoxicillin 1000 mg twice daily. Posology: one tablet of each drug in the morning and one tablet of each drug in the evening for 1 week.

Study design

Allocation

Randomised controlled trial

Primary purpose

Prevention

Eligibility

Sex/Gender

All

Age

35 Years to 75 Years

Healthy volunteers

Inclusion criteria

Type 2 diabetes. Glycosylated hemoglobin (HbA1c) less than 9.0% at screening. Body Mass Index (BMI) less than 40 kg/m2. Able and willing to give written informed consent and to comply with the requirements of the study.

Exclusion criteria

Type 1 diabetes. History of ketoacidosis or lactic acidosis. Patients treated with insulin. Patients treated with proton-pump inhibitors. Use of systemic corticosteroids during the last 3 months. History of convulsions and/or epilepsy. Impaired liver function (Alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), total bilirubin or alkaline phosphatase >2.5 x upper limit of normal (ULN)). Myocardial infarction < 6 months before screening. Presence of chronic renal failure. Serious illness, such as active cancer, major active infection, severe psychiatric disorders. Pregnant or lactating women and women with childbearing potential not using adequate method of contraception. Partecipation in a clinical trial with an investigational drug within 3 months prior to the screening examination.

Outcome results