The aim of this study is to investigate the effects of lactulose on probiotic bacteria status and blood sugar in type 2 diabetic patients. Forty patients will be randomly assigned into intervention and control groups, each containing 20 subjects. Before and after end of the study blood and stool samples will be obtained. Hb A1C; blood glucose levels and probiotic bacteria colony count of 2 grams of stool will be measured.
Inclusion criteria: type 2 diabetes; age between 30 to 70 years; HbA1c 7 to 9.
Exclusion criteria: antibiotic use; presence of acute and chronic gastrointestinal diseases leading to intestinal dysfunction; HbA1c below 7 or above 9% ; the need to change medication or diet during the study; use of medications affecting bowel function.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201210193565N7
Registration date:2014-10-08, 1393/07/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-08, 1393/07/16
Registrant information
Name
Akbar Aliasgarzadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7850
Email address
asgharzadeha@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-09-06, 1393/06/15
Expected recruitment end date
2015-01-05, 1393/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of Lactulose effects on intestinal probiotics and blood glucose in type 2 diabetic patients.
Public title
Lactulose effects on intestinal probiotics and blood glucose in diabetic patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: type II diabetes; age between 30 to 70 years; HbA1c 7 to 9.
Exclusion criteria: antibiotic use; presence of acute and chronic gastrointestinal diseases leading to intestinal dysfunction; HbA1c below 7 or above 9%; need to change medication or diet during the study; use of medications affecting bowel function such as drugs for peptic ulcers, probiotics, laxatives; no history of surgery on gastrointestinal tract and liver; the absence of other systemic diseases affecting the gastrointestinal tract such as uncontrolled hypothyroidism, renal failure, liver disease and advanced heart failure; lack of consent to participate in the study.
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences Ethics Committee
Street address
Central building II ,Third floor, Golgasht Street,Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2014-08-04, 1393/05/13
Ethics committee reference number
9371
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Blood glucose levels
Timepoint
Baseline and three months after starting the study.
Method of measurement
Paraclinical
2
Description
Hemoglobin A1C
Timepoint
Baseline and three months after starting the study
Method of measurement
Paraclinical
3
Description
Stool probiotic bactria count
Timepoint
Baseline and three months after starting the study.
Method of measurement
Culture and colony count
Secondary outcomes
empty
Intervention groups
1
Description
Patients in the intervention group receive 20,30 cc lactulose daily fo 3 months .
Category
Treatment - Drugs
2
Description
patients in control group receive their routine diabetes treatment without lactulose
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Akbar Aliasgharzadeh
Street address
Imam Reza hospital, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mehdi Farhoudi
Street address
Central building II,Third floor, Golgasht Street,Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Akbar Asgharzadeh
Position
Associate Professor, Endocrinologist
Other areas of specialty/work
Street address
Imam Reza hospital, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 7850
Fax
Email
asgharzadeha@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Akbar Asgharzadeh
Position
Associate Professor, Endocrinologist
Other areas of specialty/work
Street address
Imam Reza hospital, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 7850
Fax
Email
asgharzadeha@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Arash Khayati
Position
MD, Resident of Internal Medicine
Other areas of specialty/work
Street address
Imam Reza hospital, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 7850
Fax
Email
arash.khayati@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)