The effect of probiotic on serum adiponectin level in pre-diabetic patients.
Design
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، سه سویه کور ، تصادفی شده
Settings and conduct
At first, physical examination including height, weight and BMI is performed in the patients and then referred to the laboratory for measurement of Insulin-FBS-LDL-HDL-TG-HBA1C. In the present study, in addition to the above-mentioned tests, serum levels of adiponectin were also measured. Subsequently, patients are randomly divided into two groups, one group receiving probiotic tablets exceeding CFU 109 equivalent to 500 mg capsules daily, and the other group being given placebo. BMI is effective on adiponectin levels, with patients randomized based on BMI. After three months, the effect of the above treatment on primary laboratory parameters, systolic and diastolic blood pressure and BMI in both groups will be compared. The probiotic regimen is lactocare containing lactase and lactobacillus acidophilus. Placebo capsule The placebo drug is also a capsule that looks exactly like the drug. At the beginning of the plan, a full explanation of the effect of diet and exercise is given to all patients. Physical activity times are recommended three times a week. Patients are given diet charts.
Participants/Inclusion and exclusion criteria
inclusion
All prediabetic patients aged 30 to 65 years
exclusion
Patients with previously diagnosed diabetes treated with hypoglycemic drugs such as metformin and such
Patients with a prior diagnosis of pre-diabetes who are under medication treatment
Intervention groups
The intervention group received probiotics and the control group received placebo
Main outcome variables
Patient weight and BMI measurements, systolic and diastolic blood pressures, blood glucose test findings, HDL, LDL, HBA1C and adiponectin at baseline and thirty months after treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190801044405N1
Registration date:2020-10-25, 1399/08/04
Registration timing:prospective
Last update:2020-10-25, 1399/08/04
Update count:0
Registration date
2020-10-25, 1399/08/04
Registrant information
Name
mehrdad sarabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3601 3644
Email address
mehrdad.sarabi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-14, 1399/10/25
Expected recruitment end date
2021-07-16, 1400/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotic on serum adiponectin level in pre-diabetic patients
Public title
The effect of probiotic on serum adiponectin level in pre-diabetic patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All prediabetic patients aged 30 to 65 years
Exclusion criteria:
Patients with previously diagnosed diabetes treated with hypoglycemic drugs such as metformin and such
Patients with a prior diagnosis of pre-diabetes who are under medication treatment
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Initially, a physical examination including height, weight, BMI, and systolic and diastolic blood pressure are performed in patients. Patients are referred to the laboratory for measurement of Insulin-FBS-LDL-HDL-TG-HBA1C. Serum levels of adiponectin are also measured in the following tests. Patients are then randomly divided into two groups, one group receiving probiotic pills more than 109 CFU equivalent to 500 mg capsules daily and the other group receiving placebo. Also, given that BMI is effective on adiponectin levels, patients are randomized based on their BMI.
Blinding (investigator's opinion)
Triple blinded
Blinding description
We used odd numbers for the main drug and even numbers for placebo, patients pick a card and based on number of their card our assistant give them a pack of placebo or drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Azadi Square, east door of Ferdowsi University campus, Faculty of Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2019-04-09, 1398/01/20
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.154
Health conditions studied
1
Description of health condition studied
diabetes
ICD-10 code
R73.09
ICD-10 code description
Other abnormal glucose
Primary outcomes
1
Description
Serum adiponectin levels
Timepoint
Before intervention and after 3 months of medication
Method of measurement
blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:500mg capsules of Lactocare probiotic for 3 month, 1 capsule daily
Category
Prevention
2
Description
Control group: 500mg placebo capsules for 3 month, 1 capsule daily