Evaluating the Effect of Synbiotic Supplements on Hyperglycemia and Insulin Resistance in Patients with Type 2 Diabetes: A Randomized Double-blinded, Clinical Trial
Evaluating the Effect of Synbiotic Supplements on Hyperglycemia and Insulin Resistance in Patients with Type 2 Diabetes
Design
clinical trial with parallel groups; with two intervention groups and one control group, double-blind, randomized, on 194 patients. Random allocation software was used for randomization.
Settings and conduct
The effectiveness of synbiotic supplement on hyperglycemia and insulin resistance in patients with type 2 diabetes is investigated in the clinics of Shahid Rajaei Hospital in Tankabon and also Imam Sajad in Ramsar. Patients are divided into two groups of 97 synbiotics and control, and each group receives one tablet twice a day for 3 months. Patients, prescribers, and data analysts will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients in the age group of 30 to 75 years with type 2 diabetes who are diagnosed based on the latest American Diabetes Association(ADA) guidelines.
Exclusion criteria: Pregnant and lactating women
Patients receiving hormone therapy, including estrogen and progesterone.
Hypothyroidism
Patients with kidney disease that have a creatinine level more than two times the upper normal limit.
Consumption of any Probiotic, Synbiotic products and Antibiotics in the last three months.
Alcohol consumption
Intervention groups
97 Patients are in the synbiotic Supplements Intervention Group. Patients will receive the supplements twice daily for three months.
Main outcome variables
blood sugar ; Insulin resistance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230212057393N2
Registration date:2023-04-18, 1402/01/29
Registration timing:prospective
Last update:2023-04-18, 1402/01/29
Update count:0
Registration date
2023-04-18, 1402/01/29
Registrant information
Name
Fahimeh Naderi-Behdani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 5523 1912
Email address
fahime.naderi90@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-05, 1402/02/15
Expected recruitment end date
2023-08-06, 1402/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effect of Synbiotic Supplements on Hyperglycemia and Insulin Resistance in Patients with Type 2 Diabetes: A Randomized Double-blinded, Clinical Trial
Public title
Evaluating the Effect of Synbiotic Supplements on type 2 Diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients in the age group of 30 to 75 years with type 2 diabetes who are diagnosed based on the latest American Diabetes Association(ADA) guidelines.
Exclusion criteria:
Pregnant and lactating women
Patients receiving hormone therapy, including estrogen and progesterone.
Hypothyroidism
Patients with kidney disease that have a creatinine level more than two times the upper normal limit.
Consumption of any Probiotic, Synbiotic products and Antibiotics in the last three months.
Alcohol consumption
Age
From 30 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
194
Randomization (investigator's opinion)
Randomized
Randomization description
The method of allocating samples into two groups will be based on block classification. The blocking process will be done using random allocation software. This software will generate blocks, and samples will be studied based on the principles of random numbers generated.
Based on the above method, the studies will be divided into two synbiotic and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, physicians, and statisticians will not know the intervention distribution. Synbiotic supplements and placebo capsules are entirely similar in terms of appearance, shape, smell, and color and are distinguished from each other only by the A and B codes. Only the data safety and monitoring committee knows its contents and codes.
At the Baseline and three months after entering the trial
Method of measurement
Blood test
2
Description
Body Mass Index
Timepoint
At the Baseline and three months after entering the Trial
Method of measurement
Scale and Tape Measure
3
Description
Systolic and Diastolic Blood Pressure
Timepoint
At the baseline and three months after entering the Trial
Method of measurement
Mercury Sphygmomanometer
4
Description
measure psychological disorder
Timepoint
At the baseline and three months after entering the trial
Method of measurement
The General Health Questionnaire – 28
5
Description
Appetite assessment
Timepoint
At the Baseline and every month after entering the trial
Method of measurement
Question by the research team by phone
6
Description
Evaluating the stool condition of patients
Timepoint
At the Baseline and every month after entering the trial
Method of measurement
Question by the research team by phone
Intervention groups
1
Description
97 Patients are in the synbiotic Supplements( Familact, zisttakhmir Company) Intervention Group. Patients will receive The supplements twice daily for three months.
Category
Treatment - Drugs
2
Description
ninety-seven patients are in the control group. Patients will receive placebo with the same shape, color, and smell as our intervention supplements, twice a day for 3 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Sajad Ramsar Hospital
Full name of responsible person
Fahimeh Naderi Behdani
Street address
Enghelab Sq, Emam Sajad Hospital Ramsar, Ramsar City
City
Ramsar
Province
Mazandaran
Postal code
4691714141
Phone
+98 11 5522 2349
Email
fahime.naderi90@gmail.com
2
Recruitment center
Name of recruitment center
Shahid Rajaei Tonekabon Hospital Clinics
Full name of responsible person
Fahimeh Naderi Behdani
Street address
Emam Sajad Hospital, Enghelab Sq, Ramsar City
City
Ramsar
Province
Mazandaran
Postal code
4691888200
Phone
+98 915 769 6456
Email
fahime.naderi90@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mahsa Narenji
Street address
Enghelab Sq, Emam Sajad Hospital, Ramsar City
City
Ramsar
Province
Mazandaran
Postal code
4691714141
Phone
+98 11 5522 2349
Email
fahime.naderi90@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?