Your session is about to expire
← Back to Search
Hormone Therapy
Oxidative Stress Impact on Vascular Function After Gestational Diabetes
Phase < 1
Waitlist Available
Research Sponsored by Anna Stanhewicz, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
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 oxidative stress affects blood vessels in women who had gestational diabetes during pregnancy.
Who is the study for?
This trial is for healthy women aged 18-50 who had gestational diabetes within the last 5 years, as confirmed by ACOG criteria. It's not for those with liver or metabolic diseases, skin conditions, a history of preeclampsia or hypertension during pregnancy, current pregnancy, underweight individuals (BMI <18.5), latex allergies, drug allergies to study medications, statin users, smokers or e-cigarette users.Check my eligibility
What is being tested?
The study is looking at how oxidative stress affects small blood vessel function in women who've had gestational diabetes. Participants will receive Acetylcholine and insulin aspart to see if these can improve vascular function by reducing oxidative stress.See study design
What are the potential side effects?
Potential side effects from Acetylcholine might include flushing and low blood pressure. Insulin aspart could cause low blood sugar levels (hypoglycemia), injection site reactions like redness or swelling, itching and possible allergic reactions.
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
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 insulin-stimulated eNOS phosphorylation
endothelial cell markers of oxidative stress
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: local ascorbate perfusionExperimental Treatment2 Interventions
local ascorbate is perfused through the microdialysis fiber to serve as the antioxidant experimental treatment
Group II: local L-NAME perfusionExperimental Treatment2 Interventions
local L-NAME is perfused through the microdialysis fiber to inhibit nitric oxide synthase
Group III: 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
2002
Completed Phase 4
~9040
Find a Location
Who is running the clinical trial?
Anna Stanhewicz, PhDLead Sponsor
9 Previous Clinical Trials
354 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Skin conditionsYou have had preeclampsia or high blood pressure during pregnancy.You have a body mass index (BMI) lower than 18.5.You have been pregnant in the last 5 years.You are taking medicine to lower your cholesterol.You currently smoke cigarettes or use e-cigarettes.You have never had gestational diabetes during a pregnancy.You are between 18 and 50 years old.You are currently taking medicine for high blood pressure.You had diabetes during pregnancy that was diagnosed by your doctor and confirmed using specific criteria.You have liver or metabolic disease, including diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: local L-NAME perfusion
- Group 2: local lactated Ringer's perfusion
- Group 3: local ascorbate perfusion
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals above 35 years of age being invited to participate in this trial?
"As per the specifications of this clinical trial, only individuals aged 18 or over and no older than 50 are eligible for enrollment."
Answered by AI
What is the current number of participants involved in this research endeavor?
"Affirmative, the data presented on clinicaltrials.gov affirms that this experiment is currently recruiting participants. Initially posted on February 1st 2021 and recently amended on July 7th 2023, it requires 60 individuals from one medical site to join in the trial."
Answered by AI
Is it possible to join the clinical trial?
"Potential candidates for this trial must have a diagnosis of gestational diabetes and fall in the age range between 18 and 50. Currently, 60 patients are being sought after to participate."
Answered by AI
Have participation slots for this clinical experiment been filled?
"According to clinicaltrials.gov, this research endeavour is currently attempting to recruit patients; its inception date was February 1st 2021 and the most recent update was July 7th 2023."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger