Myoinositol Effect on Asprosin Levels

Not Applicable

Completed

• Conditions: Pregnancy Related
• Interventions: Drug: myoinositol and folic acid; Drug: folic acid

• Registration Number: NCT05943158
• Lead Sponsor: Near East University, Turkey

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.

Study Timeline

• Study Start: 2021-06-01
• Primary Completion: 2022-06-30
• Study Completion: 2023-06-15
• Study First Submitted: 2023-06-20
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-02
• Last Update Submitted: 2023-07-02
• Study First Posted: 2023-07-13
• Last Update Posted: 2023-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Myoinositol+folic acid group	myoinositol and folic acid	This group is given myoinositol+folic acid (inofolic, ITF company, Italy) (myoinositol 4 gram+folic acid 400 micrograms)
Only folic acid group	folic acid	This group is given only folic acid once a day (400 micrograms a day)

Primary Outcome Measures

Name	Time	Method
Serum asprosin levels	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

Trial Locations

Locations (1)

Near East University Faculty of Medicine; 🇨🇾 Nicosia, Cyprus