Aim: assessment of any relationship between helicobacter pylori infection and metabolic syndrome.
Inclusion criteria: patients with metabolic syndrome and infection with helicobacter pylori.
Exclusion criteria: non-consent to participation in the study; any other internal or cardiac disease; intolerance to the prescribed drugs
Study population: outpatient persons attending in internal medicine clinic with diagnosis of metabolic syndrome and infection with helicobacter pylori.
the sample size: 80
Intervention: treatment of helicobacter pylori infection and its impact on improvement of metabolic syndrome.
duration of the study: 6 months
primary outcome measures: indices of metabolic syndrome including body mass index, serum triglyceride concentration, waist circumference, blodd pressure.
General information
Acronym
helicobacter pylori and metabolic syndrome
IRCT registration information
IRCT registration number:IRCT2015020420951N1
Registration date:2015-03-09, 1393/12/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-09, 1393/12/18
Registrant information
Name
Amir Mohammad Kazemifar
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3335 6696
Email address
amkazemifar@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research department of medicine college of Qazvin University of Medical Silences; Taghi Naserpour Farivar
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
study of effects of helicobacter pylori infection on improvement of metabolic syndrome
Public title
the effect of treatment of helicobacter pylori (HP) infection on improvement of metabolic syndrome (MS)
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion: concomitant metabolic syndrome and helicobacter pylori
exclusion: no consent; any other internal or cardiac disease; intolerance to the prescribed drugs
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences
Street address
Bahonar Blvd, the University paradise
City
Qazvin
Postal code
Approval date
2015-01-07, 1393/10/17
Ethics committee reference number
28/20/9672
Health conditions studied
1
Description of health condition studied
metabolic syndrome
ICD-10 code
E88.9
ICD-10 code description
Metabolic disorder, unspecified
2
Description of health condition studied
Helicobacter pylori infection
ICD-10 code
B98.0
ICD-10 code description
Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters
Primary outcomes
1
Description
waist circimference
Timepoint
at the start and end of the study
Method of measurement
cm
2
Description
fasting blood sugar
Timepoint
at the start and end of the study
Method of measurement
mg/dl
3
Description
serum triglyceride
Timepoint
at the start and end of the study
Method of measurement
mg/dl
4
Description
blood pressure
Timepoint
at the start and end of the study
Method of measurement
milimeter of mercury
5
Description
body mass index
Timepoint
at the start and end of the study
Method of measurement
kg/m2
Secondary outcomes
empty
Intervention groups
1
Description
case group: treatment of HP infection woth opemrazole (20 mg bid), amoxicilin (1gr bid), and clarythromycin (500 mg bid)
Category
Treatment - Drugs
2
Description
the control group will receive only symptomatic therapy. the HP treatment postponed until the end of the study (if they provide informed consent)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
outpatient treatment center of QUMS
Full name of responsible person
Zahra Azariun
Street address
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
research department of medical college of QUMS
Full name of responsible person
Mahnaz Abbasi
Street address
Bahonar Blvd, the university paradise
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
research department of medical college of QUMS
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medica Sciences
Full name of responsible person
Zahra Azariun
Position
resident of internal medicine
Other areas of specialty/work
Street address
Buali hospital, Buali St.
City
Qazvin
Postal code
Phone
+98 28 3335 6696
Fax
Email
dr.houshmand@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Siences
Full name of responsible person
Bahram Mehrtash
Position
Internist
Other areas of specialty/work
Street address
Buali hospital, Buali St.
City
Qazvin
Postal code
Phone
+98 28 3335 6696
Fax
Email
bahrammeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Mohammad Kazemifar
Position
toxicologist
Other areas of specialty/work
Street address
Buali hospital, Buali St.
City
Qazvin
Postal code
Phone
+98 28 3335 6696
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)