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NADPH Oxidase Role in Gestational Diabetes

Q: To whom is enrollment in this medical experiment available?

To participate in this clinical trial, patients must have been diagnosed with gestational <a href="https://www.withpower.com/clinical-trials/diabetes">diabetes</a> and fall between 18-50 years old. The study is accommodating 40 participants at maximum capacity.

Q: How many participants is this experiment accommodating?

Affirmative. Evidence from clinicaltrials.gov demonstrates that this research is now recruiting participants, commencing on August 30th 2023 and recently updated September 13th 2023. 40 candidates are required for the single site trial.

Q: Does the trial take into account youth under 30 years old?

The minimum age of participants for this clinical trial is 18, while the maximum age is 50. There are 11 trials available to minors and 61 studies that can be accessed by people over 65 years old.

Q: Are there any available spots in this clinical investigation?

This clinical trial is currently recruiting, as indicated by the data found on clinicialtrials.gov. It was initially advertised on August 30th 2023 and has been refreshed since September 13th of the same year.

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial looks at how a protein might cause problems for pregnant women with a history of gestational diabetes.

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.Check my eligibility

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.See study design

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

Select...

I am 18 years old or older.

Select...

I was diagnosed with gestational diabetes by my doctor.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

microvascular acetylcholine-mediated dilation

microvascular insulin-mediated dilation

Secondary outcome measures

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Anna Stanhewicz, PhDLead Sponsor

9 Previous Clinical Trials

340 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To whom is enrollment in this medical experiment available?

"To participate in this clinical trial, patients must have been diagnosed with gestational diabetes and fall between 18-50 years old. The study is accommodating 40 participants at maximum capacity."

Answered by AI

How many participants is this experiment accommodating?

"Affirmative. Evidence from clinicaltrials.gov demonstrates that this research is now recruiting participants, commencing on August 30th 2023 and recently updated September 13th 2023. 40 candidates are required for the single site trial."

Answered by AI

Does the trial take into account youth under 30 years old?

"The minimum age of participants for this clinical trial is 18, while the maximum age is 50. There are 11 trials available to minors and 61 studies that can be accessed by people over 65 years old."

Answered by AI

Are there any available spots in this clinical investigation?

"This clinical trial is currently recruiting, as indicated by the data found on clinicialtrials.gov. It was initially advertised on August 30th 2023 and has been refreshed since September 13th of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Role of NADPH Oxidase in Microvascular Dysfunction Following GDM

Anna Stanhewicz, PhD 2023. "Role of NADPH Oxidase in Microvascular Dysfunction Following GDM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05946798.