Cerebral Blood Flow and Vascular Function in Women with Gestational Diabetes History
Intradermal Microdialysis
+ Brain Blood Flow Tests
+ Local Heating
Urogenital Diseases+6
+ Diabetes Mellitus
+ Endocrine System Diseases
Basic Science Study
Summary
Study start date: August 22, 2025
Actual date on which the first participant was enrolled.Gestational Diabetes Mellitus (GDM) affects about 14% of pregnancies globally, and its impact can extend well beyond the pregnancy period. Women who have had GDM are at a higher risk of developing blood vessel-related brain diseases and dementia compared to those with uncomplicated pregnancies. This study aims to understand how GDM affects blood flow in the brain and the function of brain blood vessels in healthy women who have previously had GDM or an uncomplicated pregnancy. By gaining insights into these effects, the study hopes to address the lack of information on how GDM influences brain health after pregnancy and ultimately improve future care and prevention strategies. Participants in this study will undergo non-invasive ultrasound tests to measure blood flow in the brain. The study will also evaluate how brain blood vessels respond to increased carbon dioxide levels, similar to what occurs during a breath hold. Researchers will compare these brain blood flow results with skin blood vessel function by using a gentle technique on small areas of the forearm. This involves a minor procedure to deliver medications locally under the skin. Blood samples will also be taken to assess overall health and explore factors affecting blood vessel function. This comprehensive approach helps identify potential links between GDM and brain vessel health, aiming to improve understanding of its long-term effects.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.84 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Basic Science Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
INCLUSION CRITERIA: * 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). EXCLUSION CRITERIA: We exclude participants from both groups for: * 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 * Use of prescribed NSAIDs, statins or other cholesterol-lowering medication, antihypertensive medication, carbonic anhydrase inhibitors, corticosteroids, thyroid medications, antidepressants or mood stabilizers, diuretics, phenothiazines, or benzodiazepines * History of preeclampsia or gestational hypertension, * History or family history of panic disorder, * Currently pregnant * Body mass index \<18.5 kg/m2, * Allergy to materials used during the experiment (e.g. latex), known allergies to study drugs. * History of heavy alcohol use/binge drinking, * Have planned procedures with radiological contrast, * Have a major dental procedure/surgery coming up, such as a dental extraction * Anatomy of the middle cerebral artery or internal carotid artery that prevents adequate ultrasonography and/or and data collection
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Iowa Bioscience Innovation Facility
Iowa City, United StatesOpen Iowa Bioscience Innovation Facility in Google Maps