What side effects are associated with this type of intervention?

Common treatments for gestational diabetes include insulin therapy and oral hypoglycemic agents like metformin and glyburide. Insulin therapy can cause hypoglycemia, weight gain, and injection site reactions. Metformin may lead to gastrointestinal side effects such as nausea, vomiting, and diarrhea. Glyburide can also cause hypoglycemia and, less commonly, weight gain. These treatments aim to control blood glucose levels and minimize complications for both the mother and the fetus.

What prior FDA approvals exist?

The FDA has approved several treatments for gestational diabetes, primarily focusing on insulin therapy and oral medications like metformin and glyburide. These treatments aim to control blood glucose levels effectively. Insulin therapy is the most common and is preferred when blood glucose levels are not adequately managed by diet and exercise alone. Metformin and glyburide are oral medications that have also been used, although they are less common than insulin. There are no specific FDA-approved treatments for GDM that function as NADPH oxidase inhibitors to reduce reactive oxygen species production.

What other types of research exist?

Promising alternatives to NADPH Oxidase Inhibitors for reducing ROS in gestational diabetes patients include DPP-4 inhibitors (e.g., linagliptin), SGLT2 inhibitors (e.g., empagliflozin), and GLP-1 analogs (e.g., liraglutide). These agents have shown efficacy in reducing oxidative stress in diabetes.

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NADPH Oxidase Role in Gestational Diabetes

Q: What is the mechanism of action of this treatment?

Common treatments for Gestational Diabetes Mellitus (GDM) include metformin and insulin. Metformin decreases hepatic glucose production and improves insulin sensitivity, thereby lowering blood glucose levels. Insulin therapy supplements the body's insulin to manage blood sugar. The NADPH Oxidase Inhibitor, which reduces reactive oxygen species (ROS) production, is being studied for its potential to improve microvascular function by reducing oxidative stress, a key factor in GDM complications. These treatments are crucial for managing blood glucose levels and minimizing both maternal and fetal complications associated with GDM.

Phase < 1

Recruiting

Research Sponsored by Anna Stanhewicz, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years or older

Had gestational diabetes diagnosed by their obstetrician and confirmed according to the American College of Obstetricians and Gynecologists criteria for gestational diabetes

Must not have

Diagnosed or suspected hepatic or metabolic disease including diabetes

Current antihypertensive medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the study visit, an average of 4 hours

Summary

This trial examines how an enzyme might create harmful molecules that damage blood vessels in healthy women who had diabetes during pregnancy. Researchers use a small, minimally invasive technique to deliver medicine directly to the skin and take cell samples from a vein to study stress markers.

Who is the study for?

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.

What is being tested?

The study is looking at how NADPH oxidase might cause poor blood vessel function in healthy women with past gestational diabetes by using substances like Acetylcholine and Insulin aspart to test vascular response.

What are the potential side effects?

Possible side effects from Acetylcholine may include flushing, low blood pressure, and sweating. Insulin aspart could cause reactions at the injection site, low blood sugar levels (hypoglycemia), itching or rash.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I was diagnosed with gestational diabetes by my doctor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with or suspected to have liver disease or diabetes.

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I am currently taking medication for high blood pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the study visit, an average of 4 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the study visit, an average of 4 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the study visit, an average of 4 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

microvascular acetylcholine-mediated dilation

microvascular insulin-mediated dilation

Secondary study objectives

endothelial cell NADPH oxidase expression

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: local apocynin perfusionExperimental Treatment2 Interventions

local apocynin is perfused through the microdialysis fiber to serve as the NADPH oxidase inhibited experimental treatment

Group II: local apocynin + L-NAME perfusionExperimental Treatment2 Interventions

local apocynin and L-NAME are perfused through the microdialysis fiber for dual inhibition of NADPH oxidase and nitric oxide synthase

Group III: local L-NAME perfusionExperimental Treatment2 Interventions

local L-NAME is perfused through the microdialysis fiber to inhibit nitric oxide synthase

Group IV: local lactated Ringer's perfusionPlacebo Group2 Interventions

lactated Ringer's is perfused through the microdialysis fiber to serve as the vehicle control

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acetylcholine

2013

Completed Phase 2

~220

Insulin aspart

2011

Completed Phase 4

~4140

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Gestational Diabetes Mellitus (GDM) include metformin and insulin. Metformin decreases hepatic glucose production and improves insulin sensitivity, thereby lowering blood glucose levels. Insulin therapy supplements the body's insulin to manage blood sugar. The NADPH Oxidase Inhibitor, which reduces reactive oxygen species (ROS) production, is being studied for its potential to improve microvascular function by reducing oxidative stress, a key factor in GDM complications. These treatments are crucial for managing blood glucose levels and minimizing both maternal and fetal complications associated with GDM.

Efficacy and safety of metformin in the treatment of gestational diabetes: A protocol for systematic review and meta-analysis.