MTHFR Mutation and Concentration of B12,Folic Acid,Homocysteine and HS CRP in the Blood of Pregnant Women With GDM.

NCT04952324 | Completed DMC

• 1 other identifier: MTHFR mutation and GDM
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Between 24 and 28 weeks of gestation

Study Arms (2)

Pregnant women with GDM

Pregnant women with GDM

Other: Blood sampling and determination of MTHFR mutation,vitamin B12, folic acid, homocystein and HS CRP

Pregnant women without GDM

Pregnant women without GDM

Other: Blood sampling and determination of MTHFR mutation,vitamin B12, folic acid, homocystein and HS CRP

Interventions

Blood sampling and determination of MTHFR mutation,vitamin B12, folic acid, homocystein and HS CRP OTHER

Periferal Blood sampling and determination of MTHFR mutation,vitamin B12, folic acid, homocystein and high sensitive CRP

Pregnant women with GDM; Pregnant women without GDM

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Pregnant women
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Population of women who were hospitalized at the gynecology and obstretics clinic in Mostar.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Mostar: lead

Study Sites (2)

Faculty of health studies, Mostar

Mostar, 88000, Bosnia and Herzegovina

Location

University of Mostar

Mostar, 88000, Bosnia and Herzegovina

Location

Related Publications (1)

• 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.

  PMID: 37622180 DERIVED

Related Links

• Chemical pathology of homocysteine. IV. Excitotoxicity, oxidative stress, endothelial dysfunction, and inflammation
• First-Trimester Screening for Gestational Diabetes Mellitus Based on Maternal Characteristics and History
• Endothelial dysfunction - a major mediator of diabetic vascular disease
• Inflammatory and Other Biomarkers: Role in Pathophysiology and Prediction of Gestational Diabetes Mellitus

Biospecimen

Retention: SAMPLES WITHOUT DNA

Periferal blood.

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Blood Specimen Collection; Vitamin B 12; Folic Acid; C-Reactive Protein

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Acute-Phase Proteins; Blood Proteins; Immunoproteins

Study Officials

• Vajdana Tomic, prof. dr

  Faculty of Health Studies, Mostar

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: mr. sc. Ana Boskovic, Ob/Gyn specialist

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: July 7, 2021
• Study Start: September 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginnibg 3 months and ending 5 Years folowing article publication.
• Access Criteria: Investigators whose proposed use the Data has been approved by an Independent review committee identified for this purpose.

Locations

BO (2)