The Effect of Acute Glucose Loading on Level of Expression of Advanced Glycation End Products in Women Screened for Gestational Diabetes During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Concentration of advanced glycation end products in maternal serum following the glucose load
研究概览
简要总结
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.
详细描述
A. Research Design Participants will be identified at the time of their prenatal care visit (24-28 weeks GA). The investigators will ask permission for participation in the research protocol. A waiver of HIPPA has been added to the protocol to explain the sources investigators might use to screen for eligible subjects. The electronic medical records may be accessed with a partial waiver to review the medical information that will make each subject a candidate for the protocol. The subject will be instructed on the benefits of the study for which the participant is eligible and that management will not be influenced by the participant's decision to volunteer or not. If the patient agrees to participate, the participant will be given the written consent to read. The participant will be asked if there is understanding, if all has been explained, and if there are any questions the investigators need to clarify. The informed consent will be obtained. No ads, flyers, website postings, recruitment letters, or oral/written scripts will be involved for recruitment of patients.
Interventions:
- Informed consent.
- Collection of blood (5 cc or one teaspoon of whole blood) and urine (1/2 cup) specimens prior to administration of the 50 gr. glucola test. This protocol will be presented in this arm of the study to women (n=50) who have a clinically indicated 1 hour glucose tolerance test to diagnose gestational diabetes.
- Blood pressure measurements every 15 minutes for one hour.
- Collection of a second blood (5 cc or one teaspoon of whole blood), and urine (1/2 cup) specimen following administration of the 50 gr. glucola test. Collection of blood at this time will be clinically indicated to test for abnormal clinical values that might classify the patient as gestational diabetic.
- In a separate group of women classified as healthy pregnant controls (n=50) the investigators will obtain informed consent using a protocol similar to the one described above.
- Collection of a blood (5 cc or one teaspoon of whole blood), and urine (1/2 cup) specimen will be performed prior to administration of the 50 cc of plain water.
- Blood pressure measurements will be performed every 15 minutes for one hour.
d. Collection of a second blood (5 cc or one teaspoon of whole blood), and urine (1/2 cup) sample will occur at the end of the hour.
B. Sample Participants will be enrolled based on the eligibility for a one hour GTT. Chart reviews of the clinic schedules will be performed the week prior to identify the target population for recruitment who are 24-28 weeks gestation in need of a diabetes screen.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Concentration of advanced glycation end products in maternal serum following the glucose load
时间窗: 1 hour following glucose load
biomarker
次要结局
未报告次要终点
研究者
Catalin S Buhimschi, MD
Principle Investigator
Ohio State University