Effect of Glucose Load on Expression of Advanced Glycation End Products in Women Screened for Gestational Diabetes
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|ClinicalTrials.gov Identifier: NCT03029546|
Recruitment Status : Recruiting
First Posted : January 24, 2017
Last Update Posted : January 24, 2017
The investigator's main objective is to analyze the effects of a routine prenatal care screening tool (glucola test for gestational diabetes) on maternal inflammation through assessment of maternal circulatory biomarkers and blood pressure. Improving knowledge about routine prenatal care and how a variety of screening factors affect maternal physiology allows the investigators to be educated and informed when caring for mothers with medical co-morbidities.
- Determine if an acute glucose load (50g) is associated with an in-vivo and in-vitro increase in the concentration of Advanced Glycation End Products (AGEP's) that, in turn, can impact vascular endothelial reactivity and induce an acute increase in blood pressure. Previous studies generated in the investigators' laboratory showed that circulating soluble Receptor for Advanced Glycation End Products (sRAGE) and Tumor Necrosis Factor (TNF)-a (mediator of acute inflammation) are considered markers of the extent of maternal RAGE activation and/or systemic inflammation, respectively.
- Determine how an acute glucose load (50g) at the time of normal screening for gestational diabetes induces an acute increase in the level of sRAGE and TNF-a. If the investigators' hypothesis is confirmed, the investigators will have strong confirmation of the involvement of glycation products and TNF-a in generating the acute negative clinical symptoms of women experiencing a glucose tolerance test, such as headache, nausea, sweating, and bloating.
|Condition or disease|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||105 participants|
|Official Title:||The Effect of Acute Glucose Loading on Level of Expression of Advanced Glycation End Products in Women Screened for Gestational Diabetes During Pregnancy|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2020|
50 subjects undergoing routine gestational diabetes screen with 50g glucose load.
5 subjects undergoing follow-up gestational diabetes screen with 100g glucose load.
50 subjects undergoing water ingestion with the same study measurements as the glucose load group at the same time intervals.
- Concentration of advanced glycation end products in maternal serum following the glucose load [ Time Frame: 1 hour following glucose load ]biomarker
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03029546
|Contact: Megan L Jones, MDfirstname.lastname@example.org|
|Contact: Catalin Buhimschi, MDemail@example.com|
|United States, Ohio|
|Ohio State University||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Megan L Jones, MD 913-961-1915 firstname.lastname@example.org|
|Contact: Catalin Buhimschi, MD 614-293-9217 email@example.com|
|Principal Investigator:||Catalin Buhsimchi, MD||Ohio State University|