NADPH Oxidase Role in Gestational Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how the enzyme NADPH oxidase affects blood vessel function in women who have experienced gestational diabetes. It tests various treatments to determine their impact on the production of reactive oxygen species, which can influence blood flow. The trial includes several groups: some receive experimental treatments like apocynin (an enzyme inhibitor) and L-NAME (a nitric oxide synthase inhibitor), while others receive a placebo. Women diagnosed with gestational diabetes by their doctor and who were pregnant within the last five years might be suitable candidates. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants a chance to contribute to groundbreaking medical insights.
Will I have to stop taking my current medications?
If you are currently taking statins, other cholesterol-lowering medications, or antihypertensive medications, you will need to stop, as these are part of the exclusion criteria for the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that apocynin and L-NAME have been studied in various settings, yielding interesting results. Apocynin helps reduce oxidative stress, an imbalance between harmful free radicals and protective antioxidants in the body. In studies with diabetic rats, it lowered blood sugar levels and improved insulin use, suggesting potential benefits for people with blood sugar issues.
L-NAME blocks an enzyme called nitric oxide synthase, which plays a role in various body functions. However, these findings primarily come from animal studies, so effects in humans may differ.
Specific safety information for these treatments in humans is not yet available. As this trial is in its early phase, researchers are still collecting safety data. Early-phase trials are the first step in testing new treatments on people and are crucial for understanding safety. Consider this if you are thinking about participating.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this trial because it explores the roles of NADPH oxidase and nitric oxide synthase in gestational diabetes. Unlike traditional treatments that might focus on managing blood sugar levels through medication or insulin, this trial investigates how inhibiting these enzymes can potentially address underlying causes of the condition. By using local perfusion methods with apocynin and L-NAME, researchers aim to directly target and inhibit these enzymes, offering a novel approach that could lead to more effective interventions in managing gestational diabetes. This study could pave the way for treatments that not only manage symptoms but also tackle the root of the problem.
What evidence suggests that this trial's treatments could be effective for gestational diabetes?
Research has shown that a protein called NADPH oxidase creates harmful molecules known as reactive oxygen species, which can cause problems in diabetes, including gestational diabetes mellitus (GDM). In this trial, participants may receive local apocynin perfusion, which blocks NADPH oxidase and has shown promise in animal studies for reducing this harm. For example, diabetic rats treated with apocynin had lower levels of harmful molecules linked to diabetes complications. Another treatment option in this trial is local L-NAME perfusion, which affects blood vessel function and may help with issues in GDM. Although limited information exists from human studies, these treatments might help with GDM by reducing harmful molecules and improving blood vessel health.46789
Are You a Good Fit for This Trial?
This trial is for women over 18 who had gestational diabetes within the last 5 years and are not currently pregnant. They mustn't have a history of certain conditions like preeclampsia, skin diseases, or metabolic disorders including current diabetes, and can't be on specific medications like statins or antihypertensives.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Study Visit
Participants undergo intradermal microdialysis and endothelial cell collection to examine microvascular function and NADPH oxidase expression
Follow-up
Participants are monitored for any adverse effects following the study visit
What Are the Treatments Tested in This Trial?
Interventions
- N/A
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Who Is Running the Clinical Trial?
Anna Stanhewicz, PhD
Lead Sponsor