Pre-diabetic patients are reffered for metabolic disorders more and more. Since medical treatment is still suspected in these patients, the aim of this study is to compare the control of sugar and lipid by diet and lifestyle modification alone against these methods as well as probiotic intake. Many researchers believe, probiotic consumption change the sugar homeostasis and improve the type 2 diabetes.
Design
Two arm parallel group randomized trial with blinded postoperative controlled trial
Settings and conduct
In the office, we provide the conditions that both the patient and the doctor and the assessor are unaware of the type of card and treatment received.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All diabetic patients aged 30 to 65 years with each of the following criterias:
1.Fasting blood sugar between 100 and 125
2. Blood glucose 2 hours after food between 140 and 199
3. Blood glucose 2 hours after eating 75 g of glucose from 140 to 199
4- HBA1C Between 5.7% and 6.4%
Exclusion Criterias:
Patients with previous diagnosis of diabetes
Patients with pre-diabetic diagnosis that are under medical treatment
GFR <60
A history of known digestive malformations or chronic diarrhea
Receive probiotics, antibiotics, aspirin or B vitamins during the last three months
Intervention groups
In treatment group,500 mg probiotic capsule per day for three months, and in the other group, the capsule is given as placebo.
Main outcome variables
Fasting blood sugar; HbA1c
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180527039866N1
Registration date:2018-08-02, 1397/05/11
Registration timing:registered_while_recruiting
Last update:2018-08-02, 1397/05/11
Update count:0
Registration date
2018-08-02, 1397/05/11
Registrant information
Name
Somayeh sadat Shariatmaghani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3845 8779
Email address
shariatmaghanis@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of probiotic on control of glucose and lipid index in pre-diabetic patients
Public title
The effect of probiotics in the treatment of prediabetic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All pre diabetic patients 30 to 65 years old
Exclusion criteria:
Patients with previous diagnosis of diabetes
Pre-diabetic patients that are under medical treatment
GFR<60
A history of known digestive malformations or chronic diarrhea
Receive probiotics, antibiotics, aspirin or B vitamins during the last three months
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two groups, one group being treated with probiotic pills and another group being treated with placebo.
The method of randomization is that two cards are prepared and numerical coding 1 and 2 are recorded on it. Group 1 is related to probiotics and group 2 to placebo. Each patient is drawn with one of the cards without inserting the cards. We provide the conditions that both the patient and the doctor are unaware of the type of card and the treatment received, and blindness will occur.
Blinding (investigator's opinion)
Double blinded
Blinding description
All participants in the study are unaware of the use of placebo or probiotics. They are grouped into a group based on the drawing of the card and provided with explanations that they may be in groups 1 and 2. The program Food, exercise, and how to use medication or placebo for everyone is the same.
Care provider does not know that each participant is in which groups. Randomization is done by another one, outside the clinic room.
The investigator or outcome assessor is also unaware of the status of the participants. Participants are referred to care provider after the randomization, and the questionnaire and the necessary explanations for the plan are given to them.
Data analyser also does not contact the participants and does not know which group 1 and 2 are taking placebo or medication.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad Univercity of Medical Science
Street address
Daneshgah Street.,in front of 18 Ave.,Mashhad Univercity of Medical Science
City
Mashhad
Province
Razavi Khorasan
Postal code
9138735499
Approval date
2017-11-01, 1396/08/10
Ethics committee reference number
IR.MUMS.fm.REC.1396.451
Health conditions studied
1
Description of health condition studied
Prediabetes
ICD-10 code
R73.0
ICD-10 code description
Abnormal glucose tolerance test
Primary outcomes
1
Description
Fasting Blood sugar
Timepoint
Before the intervention and three months after the intervention began
Method of measurement
Blood sampling
2
Description
HbA1c
Timepoint
Before the intervention and three months after the intervention began
Method of measurement
Blood sampling
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pre-diabetes patients with a standard definition, are treated with probiotic capsule is given at a rate of more than 109 CFUs equivalent to 500 mg of capsules, daily. The lactacactor contains lactate and lactobacillus acidophilus.
Category
Treatment - Drugs
2
Description
Control group: Pre-diabetes patients with a standard definition are are treated with placebo daily.
Mohsen Tafaghodi, Deputy of Research and Technology of Mashhad University of Medical Sciences
Street address
Daneshgah Street.,in front of 18 Ave.,Mashhad Univercity of Medical Science
City
Mashhad
Province
Razavi Khorasan
Postal code
91735951
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Somayeh sadat Shariatmaghani
Position
Assotiated professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
No 9,Rahnamaii Ave 13,Rahnamaii street.,Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
1475815944
Phone
+98 51 3845 8779
Fax
Email
shariatmaghanis@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Somayeh sadat Shariatmaghani
Position
Assotiated professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
No 9,Rahnamaii Ave 13,Rahnamaii street.,Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
1475815944
Phone
+98 51 3845 8779
Fax
Email
shariatmaghanis@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Somayeh sadat Shariatmaghani
Position
Assotiated professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
No 9,Rahnamaii Ave 13,Rahnamaii street.,Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
1475815944
Phone
+98 51 3845 8779
Fax
Email
shariatmaghanis@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information on the main consequence of participants' data after being unidentifiable is shared If authorized by Mashhad University of Medical Sciences.
When the data will become available and for how long
Six months after printing results
To whom data/document is available
Researchers working in scientific institutions
Under which criteria data/document could be used
If the type of analysis is relevant to general health.
From where data/document is obtainable
By email address:MDS resaerch@mums.ac.ir
What processes are involved for a request to access data/document
Contact with the vice chancellor for research at Mashhad University of Medical Sciences by email mentioned the above. If the university agrees, the information will be sent by email.