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临床试验/NCT06911372
NCT06911372招募中1 期

The Impact of Gestational Diabetes Mellitus on Cerebral Blood Flow and Cerebrovascular Function After Pregnancy

Anna Stanhewicz, PhD1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年8月22日最近更新:
干预措施
相关药物

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
84
试验地点
1
主要终点
Stepped hypercapnia-induced change in middle cerebral artery velocity

研究概览

简要总结

Gestational Diabetes Mellitus (GDM) currently affects approximately 14% of all pregnancies worldwide. Importantly, the health-related consequences of GDM extend well beyond pregnancy, such that women with a history of GDM have a 40% increased risk of cerebrovascular diseases and a 67% increased risk of dementia, compared to women with a history of uncomplicated pregnancy. Women with a history of GDM have impaired skin microvascular function, compared with women with a history of uncomplicated pregnancy. Therefore, it's likely that GDM results in impaired brain blood vessel function, yet there is little-to-no information regarding the effects of GDM on brain blood vessel health and function after pregnancy.

Therefore, the purpose of the study is to evaluate the effects of GDM on brain blood flow and brain blood vessel function in healthy women with either a history of GDM or uncomplicated pregnancy.

In this study, the investigators will use two different types of ultrasound to non-invasively measure brain blood flow. Brain blood vessel function will be evaluated by examining the brain blood flow responses to increases in carbon dioxide (the increases in carbon dioxide are similar to what is experienced during a breath hold). Additionally, the investigators will compare the brain blood flow results to skin microvascular function to explore potential mechanisms behind possible impairments in brain blood vessel function. Skin microvascular function will be assessed using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) on dime sized areas of the forearm. Finally, for screening purposes and to further explore potential mechanisms behind any potential impairments in brain blood vessel function, the investigators will perform blood draws to determine the metabolic health of the participants and to analyze for substances that influence blood vessel function.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Vascular Tests

Experimental

All women will complete the same protocol, regardless of pregnancy history.

干预措施: Intradermal Microdialysis (Drug)

Vascular Tests

Experimental

All women will complete the same protocol, regardless of pregnancy history.

干预措施: Brain Blood Flow Tests (Other)

Vascular Tests

Experimental

All women will complete the same protocol, regardless of pregnancy history.

干预措施: Local Heating (Other)

结局指标

主要结局

Stepped hypercapnia-induced change in middle cerebral artery velocity

时间窗: During the study visit, an average of 5 hours

Middle cerebral artery velocity responses to stepped concentrations of inhaled carbon dioxide gas

Hypercapnia-induced change in internal carotid artery diameter

时间窗: During the study visit, an average of 5 hours

Internal carotid artery shear-mediated dilation response to inhaled carbon dioxide

Change in microvascular blood flow response to increasing concentrations of acetylcholine

时间窗: During the study visit, an average of 5 hours

Cutaneous vascular vasodilator responses to acetylcholine perfusion in lactated Ringer's, ketorolac, and L-NAME treated microdialysis sites.

次要结局

未报告次要终点

研究者

发起方
Anna Stanhewicz, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Anna Stanhewicz, PhD

Assistant Professor

University of Iowa

研究点 (1)

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