Myoinositol Effect on Asprosin Levels

July 2, 2023 updated by: Ali Cenk, Near East University, Turkey

Effect of Myoinositol on Serum Asprosin Levels in Pregnant Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cyprus
      • Nicosia, Cyprus, 99138
        • Near East University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Myoinositol+folic acid group
This group is given myoinositol+folic acid (inofolic, ITF company, Italy) (myoinositol 4 gram+folic acid 400 micrograms)
Drug: myoinositol and folic acid
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)
Other Names:
  • inofolic, ITF company
Experimental: Only folic acid group
This group is given only folic acid once a day (400 micrograms a day)
Drug: folic acid
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)
Other Names:
  • folidoce, ITF company

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum asprosin levels
Time Frame: between 5-8 weeks of gestation
First measurement of serum asprosin level at initial examination
between 5-8 weeks of gestation
Serum asprosin levels
Time Frame: between 24-28 weeks of gestation which the oral glucose tolerance test is done
Serum asprosin measurement at the time of oral glucose tolerance test
between 24-28 weeks of gestation which the oral glucose tolerance test is done

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Near East University, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 15, 2023

Study Registration Dates

First Submitted

June 20, 2023

First Submitted That Met QC Criteria

July 2, 2023

First Posted (Actual)

July 13, 2023

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 2, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pregnancy ASP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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