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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 4191 0
Helicobacter pylori 4503 0
Condition category
Condition code
Metabolic and Endocrine 4401 4401 0 0
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] 3908 0
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] 5285 0
Absolute/relative change in insulin resistance, K index of Insulin Tolerance Test (KITT).
Timepoint [1] 5285 0
2 timepoints: at baseline and at the end of treatment
Primary outcome [2] 5286 0
Absolute/relative change in insulin resistance, Homeostasis Model Assessment (HOMA) index.
Timepoint [2] 5286 0
2 timepoints: at baseline and at the end of treatment
Primary outcome [3] 5287 0
Absolute change in Fasting Plasma Glucose (measured by standard laboratory procedures).
Timepoint [3] 5287 0
2 timepoints: at baseline and at the end of treatment
Secondary outcome [1] 8896 0
Absolute/relative change in insulin-sensitivity related factors
(hypertension, Body Mass Index (BMI), waist, Waist/Hip ratio).
Timepoint [1] 8896 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1526 0
Italy
State/province [1] 1526 0

Funding & Sponsors
Funding source category [1] 4370 0
Hospital
Name [1] 4370 0
Istituto Nazionale Riposo e Cura Anziani (INRCA) Hospital
Address [1] 4370 0
Via Santa Margherita 5 - I-60124 ANCONA
Country [1] 4370 0
Italy
Primary sponsor type
Hospital
Name
INRCA Hospital
Address
Via Santa Margherita 5 - I-60124 ANCONA
Country
Italy
Secondary sponsor category [1] 3936 0
Commercial sector/Industry
Name [1] 3936 0
ASTRA ZENECA S.p.A.
Address [1] 3936 0
Via Francesco Sforza- I-20080-Basilio (MI)
Country [1] 3936 0
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 35085 0
Address 35085 0
Country 35085 0
Phone 35085 0
Fax 35085 0
Email 35085 0
Contact person for public queries
Name 12432 0
Roberto Testa
Address 12432 0
c/o INRCA -Via della Montagnola 81 - I-60131 Ancona (AN)
Country 12432 0
Italy
Phone 12432 0
+39 071 8003854
Fax 12432 0
+39 071 8003550
Email 12432 0
r.testa@inrca.it
Contact person for scientific queries
Name 3360 0
Roberto Testa
Address 3360 0
c/o INRCA -Via della Montagnola 81 - I-60131 Ancona (AN)
Country 3360 0
Italy
Phone 3360 0
+39 071 8003854
Fax 3360 0
+39 071 8003550
Email 3360 0
r.testa@inrca.it

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary