Gestational DiabetesNCT04952324
MTHFR Mutation and Concentration of B12,Folic Acid,Homocysteine and HS CRP in the Blood of Pregnant Women With GDM.
An observational study of Gestational Diabetes, run by University of Mostar at 2 sites in Bosnia and Herzegovina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Blood sampling and determination of MTHFR mutation,vitamin B12, folic acid, homocystein and HS CRP
- How many people
- 100 participants
- Where
- 2 sitesBosnia and Herzegovina
- Study dates
- 1 Sep 2020to 31 Dec 2022
- How long will I take part?
- 5 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Adult
Study population: Population of women who were hospitalized at the gynecology and obstretics clinic in Mostar.
Who may be able to join
- age of respondents from 18 to 35 years
- Single pregnancies BMI from 18.5 to 29.9 kg / m 2
Who cannot join
- Diagnosis of acute and chronic inflammatory diseases
- Pregestational diabetes
- Chronic hypertension
- Multiple pregnancies
- Smoking
Trial locations and contacts
2 sites in 1 country.
Bosnia and Herzegovina2 sites
Faculty of health studies, Mostar
Mostar, 88000
University of Mostar
Mostar, 88000
About this study
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.
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
Read the 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.
- Conditions
- Gestational Diabetes
- Being tested
- Blood sampling and determination of MTHFR mutation,vitamin B12, folic acid, homocystein and HS CRP
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling and determination of MTHFR mutation,vitamin B12, folic acid, homocystein and HS CRPOther
Periferal Blood sampling and determination of MTHFR mutation,vitamin B12, folic acid, homocystein and high sensitive CRP
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with GDM | Pregnant women with GDM Receives: Other: Blood sampling and determination of MTHFR mutation,vitamin B12, folic acid, homocystein and HS CRP | |
| Pregnant women without GDM | Pregnant women without GDM Receives: Other: Blood sampling and determination of MTHFR mutation,vitamin B12, folic acid, homocystein and HS CRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether increased hs crp and homocysteine values are associated with poorer perinatal outcome
We will meassure hs CRP and homocysteine levels in pregnant women with GDM and compare to hs CRP and homocysteine levels in pregnant women with normal glucose metabolism
Measured: Between 24 and 28 weeks of gestation
carriers of the MTHFR gene mutation have higher serum homocysteine concentrations in the blood
We will compare serum homocysteine levels in pregnant carriers of the MTHFR gene mutation and pregnant women normal MTHFR gene mutation.
Measured: Between 24 and 28 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start1 Sep 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 5 Months
Sponsor and investigators
- Lead sponsor
- University of Mostar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Bošković, University of Mostar
- Investigators
- Vajdana Tomic, prof. dr, Study chair, Faculty of Health Studies, Mostar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952324
- Sponsor's protocol ID
- MTHFR mutation and GDM
- Status last verified
- Apr 2023
- First submitted
- 31 May 2021
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Publications
Boskovic A, Cuk A, Mandrapa V, Dugandzic Simic A, Cvetkovic I, Orlovic Vlaho M, Kresic T, Tomic T, Tomic V. Association of MTHFR polymorphism, folic acid and vitamin B12 with serum homocysteine levels in pregnant women. Biomol Biomed. 2024 Jan 3;24(1):138-143. doi: 10.17305/bb.2023.9260.
PubMed 37622180
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04952324
- Acronym / sponsor ID
- MTHFR mutation and GDM
- Conditions
- Gestational Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of MostarUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with GDM | – | Other: Blood sampling and determination of MTHFR mutation,vitamin B12, folic acid, homocystein and HS CRPPregnant women with GDM |
| Pregnant women without GDM | – | Other: Blood sampling and determination of MTHFR mutation,vitamin B12, folic acid, homocystein and HS CRPPregnant women without GDM |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Population of women who were hospitalized at the gynecology and obstretics clinic in Mostar.
Key inclusion criteria (2 listed)
- age of respondents from 18 to 35 years
- Single pregnancies BMI from 18.5 to 29.9 kg / m 2
Key exclusion criteria (5 listed)
- Diagnosis of acute and chronic inflammatory diseases
- Pregestational diabetes
- Chronic hypertension
- Multiple pregnancies
- Smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling and determination of MTHFR mutation,vitamin B12, folic acid, homocystein and HS CRPPeriferal Blood sampling and determination of MTHFR mutation,vitamin B12, folic acid, homocystein and high sensitive CRP | Other | Pregnant women with GDM, Pregnant women without GDM |
Primary outcome
Whether increased hs crp and homocysteine values are associated with poorer perinatal outcome
Time frame: Between 24 and 28 weeks of gestation
We will meassure hs CRP and homocysteine levels in pregnant women with GDM and compare to hs CRP and homocysteine levels in pregnant women with normal glucose metabolism
carriers of the MTHFR gene mutation have higher serum homocysteine concentrations in the blood
Time frame: Between 24 and 28 weeks of gestation
We will compare serum homocysteine levels in pregnant carriers of the MTHFR gene mutation and pregnant women normal MTHFR gene mutation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Derived from this study: PubMed 37622180Boskovic A, Cuk A, Mandrapa V, Dugandzic Simic A, Cvetkovic I, Orlovic Vlaho M, Kresic T, Tomic T, Tomic V. Association of MTHFR polymorphism, folic acid and vitamin B12 with serum homocysteine levels in pregnant women. Biomol Biomed. 2024 Jan 3;24(1):138-143. doi: 10.17305/bb.2023.9260.
- Chemical pathology of homocysteine. IV. Excitotoxicity, oxidative stress, endothelial dysfunction, and inflammationLink provided by the sponsor.
- First-Trimester Screening for Gestational Diabetes Mellitus Based on Maternal Characteristics and HistoryLink provided by the sponsor.
- Endothelial dysfunction - a major mediator of diabetic vascular diseaseLink provided by the sponsor.
- Inflammatory and Other Biomarkers: Role in Pathophysiology and Prediction of Gestational Diabetes MellitusLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vajdana Tomic, prof. dr study chair
Faculty of Health Studies, Mostar
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes, run by University of Mostar at 2 sites in Bosnia and Herzegovina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bosnia and Herzegovina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whether increased hs crp and homocysteine values are associated with poorer perinatal outcome (time frame: Between 24 and 28 weeks of gestation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04952324, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.