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NCT Number: NCT06911372

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

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.

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Key information

Conditions

Gestational Diabetes Mellitus (GDM) Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Postpartum Women Pregnancy Complications Uncomplicated Pregnancy Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intradermal Microdialysis

Drug

A 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

Participants will complete CO2 breathing procedures to evaluate brain blood vessel health.

Local Heating

Other

A dime-sized heater will be placed on the skin to evaluate cutaneous microvascular function

Primary outcomes

  1. Stepped hypercapnia-induced change in middle cerebral artery velocity

    Time frame: During the study visit, an average of 5 hours

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

  2. Hypercapnia-induced change in internal carotid artery diameter

    Time frame: During the study visit, an average of 5 hours

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

  3. Change in microvascular blood flow response to increasing concentrations of acetylcholine

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Reid-Stanhewicz, PHD

CONTACT

[email protected]

319-467-1732

Sponsors and collaborators

Lead sponsor

Anna Stanhewicz, PhD

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 4, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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