Comparison of probiotic capsules and placebo on fasting blood sugar and metabolic parameters in pregnant woman with gestational diabetes or impaired glucose tolerance test
Study is a randomized controlled double-blind traial that comparison effects of use of probiotic supplements, or placebo on the level of fasting blood glucose, lipids and blood pressure in women with impaired glucose tolerance or gestational diabetes. One hundred Patients that age of pregnancy below 34 weeks without medication refer to prenatal clinic in Al-Zahra hospital of Guilan University of Medical Sciences in 1394. Diagnosis based on a three-hour oral glucose tolerance test based on carpenter criteria by internist. Inclusion criteria were single pregnancy; gestational diabetes or impaired glucose tolerance in recent pregnancy; less than 34 weeks gestational age and don't use of medication such as insulin or metformin. Exclusion criteria included overt diabetes; fetal anomalies; with out prenatal care and do not use of probiotics.The first step during the first visit after 12 hours of fasting, blood sample to measure the FBS, triglyceride, total cholesterol, HDL and LDL is taken. The patient's blood pressure in standard conditions after 10 minutes of rest are recorded.Bottles contains 30 capsules (type A and B) were given randomly for a month. After 4 weeks, second blood sample were taken to measure the FBS, triglyceride and total cholesterol, HDL and LDL.The patient's blood pressure is recorded under standard condition.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110310089N4
Registration date:2016-02-01, 1394/11/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-01, 1394/11/12
Registrant information
Name
Roya Faraji Darkhaneh
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
h_fertility@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of probiotic capsules and placebo on fasting blood sugar and metabolic parameters in pregnant woman with gestational diabetes or impaired glucose tolerance test
Public title
Impact of probiotics in gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusions criteria: single pregnancy; new diagnosis
of IGT or GDM in the current pregnancy; <34 weeks’ gestation; without insulin or metformin therapy. Exclusions criteria: pregestational diabetes; fetal anomaly; without follow; do not use of probiotics
Age
From 18 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Sciences
Street address
Reaserch and technology adjustancy of Guilan university of Medical sciences, Gas palace, Rasht, Guilan,Iran
City
Rasht
Postal code
41938-93345
Approval date
2014-10-19, 1393/07/27
Ethics committee reference number
IR.GUMS.REC.1394.308
Health conditions studied
1
Description of health condition studied
Gestational diabetes
ICD-10 code
024.4
ICD-10 code description
Diabetes mellitus arising in pregnancy
Primary outcomes
1
Description
Probiotics user
Timepoint
Baseline
Method of measurement
use probiotic capsule
2
Description
placebo user
Timepoint
baseline
Method of measurement
use placebo capsule
Secondary outcomes
1
Description
Fasing blood glocose
Timepoint
Baselie and 4 weeks after intervention
Method of measurement
Blood sample
2
Description
Triglyceride
Timepoint
Baselie and 4 weeks after interventin
Method of measurement
Blood sample
3
Description
Total cholestrol
Timepoint
Baseline and 4 weeks after intervention
Method of measurement
Blood sample
4
Description
Low density lipoprotein(LDL)
Timepoint
Baseline and 4 weeks after intrevention
Method of measurement
Blood sample
5
Description
High density lipoprotein
Timepoint
Baseline and 4 weeks after intervention
Method of measurement
Blood sample
6
Description
Blood pressure
Timepoint
Baseline and 4 weeks aftr intervention
Method of measurement
With manometer in standard position
Intervention groups
1
Description
Give to patients a bottle contains 30 capsules of probiotics with brand Lactofem from Zist takhmir company that is for a month. Capsules should be taken daily.
Category
Treatment - Drugs
2
Description
Give to patients a bottle contains 30 capsules of placebo with from Zist takhmir company that is for a month. Capsules should be taken daily.