Effect of Glucose Load on Expression of Advanced Glycation End Products in Women Screened for Gestational Diabetes

Completed

Conditions studied: Inflammation

In brief

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.

Key facts

Study ID

NCT03029546

Run by

Ohio State University

People needed

105

Starts

2015-11-01

Expected to finish

2019-11-01

Last updated by the study team

2021-04-30

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 50 pregnant women in the high risk clinic presenting for diabetes screen with 50g glucose load at a routine prenatal visit will be recruited for enrollment.
• 5 pregnant women presenting for follow-up diabetes screen with 100g glucose load.
• 50 healthy pregnant women in the general obstetric clinic at McCampbell Hall will be recruited as controls to ingest a 50cc sample of water and undergo identical objective measurements (blood pressure measurements and urine/ blood samples) as the glucose loading subjects.

You may not qualify if…

• Non-English-speaking subjects will be excluded due to inability to appropriately consent.
• Non-pregnant patients will be excluded since this is a study of maternal tissues and pregnancy outcomes related to exposures in pregnancy.
• Men will be excluded since this is a study that includes pregnant women only by nature of the research.
• Prisoners will be excluded to avoid any potential for coercion
• Minors under 18 years of age will be excluded due to lack of ability to consent without a legal guardian.
• Patients with contra-indications to glucola testing for gestational diabetes screening will be excluded, such as bariatric surgery, inflammatory bowel disease with partial bowel resection, and other mal-absorptive conditions.

Where it is running

• Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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