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Trial registered on ANZCTR

Registration number

ACTRN12609000255280

Ethics application status

Approved

Date submitted

3/02/2009

Date registered

13/05/2009

Date last updated

8/01/2010

Type of registration

Retrospectively registered

Titles & IDs

Public title

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

Scientific title

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.

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

type 2 diabetes

Helicobacter pylori

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Placebo control group, 3 tablets in the morning and 3 tablets in the
evening for 1 week. Components of the placebo tablet: tartaric acid, stearate magnesium, silicium dioxide, corn gelatin.

Control group

Placebo

Outcomes

Primary outcome [1]

Absolute/relative change in insulin resistance, K index of Insulin Tolerance Test (KITT).

Timepoint [1]

2 timepoints: at baseline and at the end of treatment

Primary outcome [2]

Absolute/relative change in insulin resistance, Homeostasis Model Assessment (HOMA) index.

Timepoint [2]

2 timepoints: at baseline and at the end of treatment

Primary outcome [3]

Absolute change in Fasting Plasma Glucose (measured by standard laboratory procedures).

Timepoint [3]

2 timepoints: at baseline and at the end of treatment

Secondary outcome [1]

Absolute/relative change in insulin-sensitivity related factors
(hypertension, Body Mass Index (BMI), waist, Waist/Hip ratio).

Timepoint [1]

2 timepoints: at baseline and at the end of treatment

Eligibility

Key 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.

Minimum age

35 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

Key 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.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

We planned to enroll 300 patients as it is statistically foreseeable that around half diabetic subjects will be Helicobacter pylori positive. These positive patients will be divided into two groups with a placebo/treatment (75 patients per treatment arm). Allocation will be concealed by sealed opaque envelopes.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

24/10/2007

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

300

Accrual to date

Final

Recruitment outside Australia

Country [1]

Italy

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Istituto Nazionale Riposo e Cura Anziani (INRCA) Hospital

Address [1]

Via Santa Margherita 5 - I-60124 ANCONA

Country [1]

Italy

Primary sponsor type

Hospital

Name

INRCA Hospital

Address

Via Santa Margherita 5 - I-60124 ANCONA

Country

Italy

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

ASTRA ZENECA S.p.A.

Address [1]

Via Francesco Sforza- I-20080-Basilio (MI)

Country [1]

Italy

Ethics approval

Ethics application status

Approved

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Roberto Testa

Address

c/o INRCA -Via della Montagnola 81 - I-60131 Ancona (AN)

Country

Italy

Phone

+39 071 8003854

Fax

+39 071 8003550

[email protected]

Contact person for scientific queries

Name

Roberto Testa

Address

c/o INRCA -Via della Montagnola 81 - I-60131 Ancona (AN)

Country

Italy

Phone

+39 071 8003854

Fax

+39 071 8003550

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Randomized, double-blind, placebo-controlled trial to evaluate the effect of Helicobacter pylori eradication on glucose homeostasis in type 2 diabetic patients.	2016	https://dx.doi.org/10.1016/j.numecd.2016.06.012

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically