Myoinositol Effect on Asprosin Levels
Primary Purpose
Pregnancy Related
Status
Completed
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
myoinositol and folic acid
folic acid
Sponsored by
About this trial
This is an interventional treatment trial for Pregnancy Related focused on measuring pregnancy, myoinositol, asprosin
Eligibility Criteria
Inclusion Criteria: Healthy pregnant women between 18-40 ages Exclusion Criteria: chronic hypertension, pre-pregnancy diabetes or a history of GDM in a previous pregnancy, multiple pregnancy, history of pregnancy-induced hypertension, addiction such as smoking or alcohol, thyroid or other endocrine diseases
Sites / Locations
- Near East University Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Myoinositol+folic acid group
Only folic acid group
Arm Description
This group is given myoinositol+folic acid (inofolic, ITF company, Italy) (myoinositol 4 gram+folic acid 400 micrograms)
This group is given only folic acid once a day (400 micrograms a day)
Outcomes
Primary Outcome Measures
Serum asprosin levels
First measurement of serum asprosin level at initial examination
Serum asprosin levels
Serum asprosin measurement at the time of oral glucose tolerance test
Secondary Outcome Measures
Full Information
NCT ID
NCT05943158
First Posted
June 20, 2023
Last Updated
July 2, 2023
Sponsor
Near East University, Turkey
1. Study Identification
Unique Protocol Identification Number
NCT05943158
Brief Title
Myoinositol Effect on Asprosin Levels
Official Title
Effect of Myoinositol on Serum Asprosin Levels in Pregnant Women
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Near East University, Turkey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Asprosin is aa adipokine associated with glucose and insulin metabolism. Insulin and glucose metabolism change during pregnancy and studies examining asprosin levels during pregnancy are increasing rapidly. Considering the beneficial effects of myo-inositol to support the physiological pregnancy, recovering and pre-venting adverse maternal and fetal outcomes, we aimed to evaluate the effects of its supplementation on serum asprosin levels in pregnant women.
Detailed Description
Asprosin, which was first mentioned in an article in 2016, is a pluripotent adipokine that is a product of profibrillin and its main source is white adipose tissue. It has been observed that asprosin is associated with glucose metabolism, and its plasma level increases after overnight fasting and decreases after feeding. After the demonstration that asprosin increases glucose secretion from the liver, subsequent studies have determined that its serum levels are increased in type 2 diabetes, human and mouse models with insulin resistance, positively correlates with obesity, and high asprosin levels have been associated with metabolic syndrome.
Pregnancy is known to be a diabetogenic process and insulin resistance is increased during gestation. Also, it is known that there is an increase in the production of adipokines during pregnancy. There are a limited number of studies in pregnancy on asprosin which is known to be produced also from the placenta. Studies examining asprosin in pregnancy in the literature mostly examined the relationship between gestational diabetes (GDM). GDM, which is defined as glucose intolerance with variable severity of hyperglycemia that occurs during pregnancy, is the most common metabolic disorder during pregnancy and its prevalence varies between 5-10% according to the patient population examined and the diagnostic test used. In addition, these patients also have impaired insulin secretion. Recently, it has been shown that asprosin levels are increased in the blood of patients with GDM.
Inositol is a polyol structure molecule belonging to the vitamin B complex, which can be produced in many organs in the body and can also be taken from the outside with food. Myo-inositol (MI) is one of the most important of the 9 inositol stereoisomers, and this molecule has been studied many times in the literature in recent years. In the literature, it is stated that inositol supplementation started in the early weeks of pregnancy prevents GDM onset, especially in women in the risk group for developing GDM like obesity, polycystic ovary syndrome, etc.. MI, which is an intracellular second messenger and has insulin-like effects on glucose metabolism, also reduces insulin resistance.
Based on these data in the literature, it can be thought that altered serum asprosin levels during pregnancy may play a role in the pathogenesis of GDM. In addition, it can be suggested that MI, which have proven effects on glucose metabolism, may have an effect on serum levels of asprosin, which is considered a new insulin resistance marker. In this study, we aimed to examine the effect of the MI on serum asprosin levels of women, which was started in the early stages of pregnancy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related
Keywords
pregnancy, myoinositol, asprosin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Myoinositol+folic acid group
Arm Type
Experimental
Arm Description
This group is given myoinositol+folic acid (inofolic, ITF company, Italy) (myoinositol 4 gram+folic acid 400 micrograms)
Arm Title
Only folic acid group
Arm Type
Experimental
Arm Description
This group is given only folic acid once a day (400 micrograms a day)
Intervention Type
Drug
Intervention Name(s)
myoinositol and folic acid
Other Intervention Name(s)
inofolic, ITF company
Intervention Description
The pregnant women were given myoinositol+folic acid starting from initial examination of pregnancy until 24-28 weeks of gestation (time of oral glucose tolerance test)
Intervention Type
Drug
Intervention Name(s)
folic acid
Other Intervention Name(s)
folidoce, ITF company
Intervention Description
The pregnant women were given only folic acid starting from initial examination of pregnancy until 24-28 weeks of gestation (time of oral glucose tolerance test)
Primary Outcome Measure Information:
Title
Serum asprosin levels
Description
First measurement of serum asprosin level at initial examination
Time Frame
between 5-8 weeks of gestation
Title
Serum asprosin levels
Description
Serum asprosin measurement at the time of oral glucose tolerance test
Time Frame
between 24-28 weeks of gestation which the oral glucose tolerance test is done
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy pregnant women between 18-40 ages
Exclusion Criteria:
chronic hypertension,
pre-pregnancy diabetes or a history of GDM in a previous pregnancy,
multiple pregnancy,
history of pregnancy-induced hypertension,
addiction such as smoking or alcohol,
thyroid or other endocrine diseases
Facility Information:
Facility Name
Near East University Faculty of Medicine
City
Nicosia
ZIP/Postal Code
99138
Country
Cyprus
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
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27087445
Citation
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Myoinositol Effect on Asprosin Levels
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