The Impact of Gestational Diabetes Mellitus on Cerebral Blood Flow and Cerebrovascular Function After Pregnancy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorAnna Stanhewicz, PhD
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Post-partum women
18 years or older
Delivered within 5 years from the study visit
History of gestational diabetes diagnosed by an obstetrician and confirmed according to the American College of Obstetricians and Gynecologists criteria for gestational diabetes OR history of uncomplicated pregnancy (defined as no history of gestational diabetes, hypertensive pregnancy, or other gestational disorder).
Disqualifiers
Skin diseases
Current tobacco use
Diagnosed or suspected hepatic or metabolic disease including diabetes
Diagnosed with depression or other mood-related disorders, asthma, chronic obstructive pulmonary disease, cystic fibrosis, or pulmonary fibrosis
Trial design
Design model
Single group
Treatments tested in this trial
Intradermal Microdialysis
DrugA total of three microdialysis sites will be perfused with ringer's solution, L-NAME, or ketorolac (one drug per site). After a baseline period, all three sites will undergo tests of blood vessel function including an acetylcholine dose-response protocol and a test of maximal skin blood flow with sodium nitroprusside.
Brain Blood Flow Tests
Other interventionParticipants will complete CO2 breathing procedures to evaluate brain blood vessel health.
Local Heating
Other interventionA dime-sized heater will be placed on the skin to evaluate cutaneous microvascular function
Treatment groups
84 Participants
are divided into 1 treatment groupGroup A: Vascular TestsExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Stepped hypercapnia-induced change in middle cerebral artery velocity
Middle cerebral artery velocity responses to stepped concentrations of inhaled carbon dioxide gas
Time frame
During the study visit, an average of 5 hours2
Hypercapnia-induced change in internal carotid artery diameter
Internal carotid artery shear-mediated dilation response to inhaled carbon dioxide
Time frame
During the study visit, an average of 5 hours3
Change in microvascular blood flow response to increasing concentrations of acetylcholine
Cutaneous vascular vasodilator responses to acetylcholine perfusion in lactated Ringer's, ketorolac, and L-NAME treated microdialysis sites.
Time frame
During the study visit, an average of 5 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Anna Stanhewicz, PhD
Lead sponsor
University of Iowa
Sponsor institution
Source ClinicalTrials.gov