Clinical trial NCT04952324: MTHFR Mutation and Concentration of B12,Folic Acid,Homocysteine and HS CRP in the Blood of Pregnant Women With GDM.
Official title: MTHFR Gene Mutation C6777T and Concentration of Vitamin B12, Folic Acid, Homocysteine and High Sensitive CRP in the Blood of Pregnant Women With Gestational Diabetes Mellitus.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes
Lead sponsor: University of Mostar
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population of women who were hospitalized at the gynecology and obstretics clinic in Mostar.

Brief summary: Research hypothesis:

* pregnant women with gestational diabetes have elevated serum CRP values and homocysteine compared to pregnant women with normal glucose metabolism
* Elevated CRP and homocysteine values are associated with poorer perinatal outcome.
* reduced concentrations of folic acid and vitamin B 12 are associated with higher homocitein values
* Carriers of the MTHFR gene mutation have higher homocysteine concentrations

Detailed description: Research issues:

The basic pathophysiological mechanism of gestational diabetes is insulin resistance formed as a result of the production of placental hormones. It turned out as atherosclerosis, chronic cardiovascular diseases and diabetes share common pathophysiological mechanisms, which is nonphysiological activation of the endothelium. CRP is an acute phase protein that is synthesized in the liver to stimulate IL-6. It is a sensitive marker of inflammation and good predictor of the development of preeclampsia while the research results CRP as a predictor of gestational diabetes inconsistent. Homocysteine is a marker of endothelial dysfunction and oxidative stress. Elevated homocysteine levels are a factor risk of cardiovascular disease, and in pregnancy is associated with preeclampsia, spontaneous abortions and placental abruption.Proper adjustment of uteroplacental blood vessels is necessary for the orderly course of pregnancy these deviations from normal endothelial function will lead to pregnancy disorders.

This study is an extrapolation of recognized markers of cardiovascular risk to gestational diabetes for the purpose of predicting an adverse perinatal outcome. Examined the association of the combination of the hs-CRP marker and homocysteine with gestational diabetes and pregnancy outcome and the correlation of homocysteine and folic acid concentration acid and vitamin B12.

Research hypothesis:

* pregnant women with gestational diabetes have elevated serum CRP values and homocysteine compared to pregnant women with normal glucose metabolism
* Elevated CRP and homocysteine values are associated with poorer perinatal outcome.
* reduced concentrations of folic acid and vitamin B 12 are associated with higher homocitein values
* Carriers of the MTHFR gene mutation have higher homocysteine concentrations

Research goals:

* compare serum values of hs-CRP and homocysteine in pregnant women with gestational diabetes and in the control group of pregnant women with a regular sugar load test
* determine the existence of an association between the values of hs-CRP and homocysteine with complications of pregnancy.
* determine the existence of a correlation between the values of vitamin B12 and folic acid with serum homocysteine values
* determine the association of MTHFR gene mutation and homocysteine concentration The objectives of the research are achievable by the proposed research.

Respondents:

* Study group: 100 pregnant women hospitalized for sugar profile in the Department pathology of pregnancy, Clinic for Gynecology and Obstetrics, SKB Mostar, and which was previously diagnosed with gestational diabetes
* Control group: 100 pregnant women with a regular glucose load test, and which meet the inclusion criteria

Criteria for inclusion in the research:

* Age of respondents from 18 to 35 years
* Single pregnancies BMI from 18.5 to 29.9 kg / m 2

Exclusion criteria:

* Diagnosis of acute and chronic inflammatory diseases
* Pregestational diabetes
* Chronic hypertension
* Multiple pregnancies
* Smoking

This enzyme is important for the metabolism of folate, B12, homocysteine.The diagnosis of gestational diabetes will be based on the results of the HAPO study, which is also accepted by the WHO. All respondents will be measured values of hs-CRP, homocysteine, folic acid and vitamin B12 in serum, at gestational age between 24-28 weeks of gestation and compare between test and control groups. The correlation of folate acid and vitamin B12 it will be examined the conection between homocysteine values in serum.

Using patients' medical histories we will monitore examined parameters: birth weight and length of the newborn, Apgar sum newborns in the 1st and 5th minutes, the development of hypertensive pregnancy disorders (hypertension, preeclampsia), HbA1c, BMI values and weight gain in pregnancy, gestational age, frequency of induced labor, cesarean section and surgically completed vaginal delivery, frequency of shoulder dystocia, presence meconium fruits, polyhydramnios, oligohydramnios and hypothyroidism. Statistical analysis of the data will assess the association of pregnancy outcomes with hs-CRP and homocysteine values in both study groups of pregnant women.

Eligibility criteria: Inclusion Criteria:

* age of respondents from 18 to 35 years
* Single pregnancies BMI from 18.5 to 29.9 kg / m 2

Exclusion Criteria:

* Diagnosis of acute and chronic inflammatory diseases
* Pregestational diabetes
* Chronic hypertension
* Multiple pregnancies
* Smoking

Primary outcomes:
measure: Whether increased hs crp and homocysteine values are associated with poorer perinatal outcome
timeFrame: Between 24 and 28 weeks of gestation
measure: carriers of the MTHFR gene mutation have higher serum homocysteine concentrations in the blood
timeFrame: Between 24 and 28 weeks of gestation
Secondary outcomes:
Other outcomes:
Locations:
city: Mostar
country: Bosnia and Herzegovina
facility: Faculty of health studies, Mostar
city: Mostar
country: Bosnia and Herzegovina
facility: University of Mostar
Study officials:
affiliation: Faculty of Health Studies, Mostar
name: Vajdana Tomic, prof. dr
role: STUDY_CHAIR
References: