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New treatment option for Gestational Diabetes Mellitus (GDM)
Official title The Impact of Gestational Diabetes Mellitus on Cerebral Blood Flow and Cerebrovascular Function After Pregnancy
ClinicalTrials.gov ID: NCT06911372
What this study is testing
What is Intradermal Microdialysis?
Intradermal Microdialysis is an investigational medicine, being studied as a potential treatment for gestational diabetes mellitus (gdm).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- 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...
See the full eligibility 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Iowa City, Iowa, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Iowa City, Iowa, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.