Gestational DiabetesEarly Phase 1NCT05946798
Role of NADPH Oxidase in Microvascular Dysfunction Following GDM
A Early Phase 1 study testing Acetylcholine and Insulin aspart in people with Gestational Diabetes and Oxidative Stress, run by Anna Stanhewicz, PhD at 1 site in United States.
Trial summary
The purpose of this investigation is to examine NADPH oxidase as a source of reactive oxygen species contributing to aberrant microvascular function in otherwise healthy women with a history of GDM. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, Oxidative Stress, Vascular Endothelial Function
- What is being tested?
- Acetylcholine and Insulin aspart
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2023to 1 Jun 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 years or older
- pregnant within 5 years of the study visit
- had gestational diabetes diagnosed by their obstetrician and confirmed according to the American College of Obstetricians and Gynecologists criteria for gestational diabetes.
- or without a history of gestational diabetes
Who cannot join
- skin diseases
- current tobacco or electronic cigarette/vape pen use,
- diagnosed or suspected hepatic or metabolic disease including diabetes,
- statin or other cholesterol-lowering medication,
- current antihypertensive medication,
- history of preeclampsia or gestational hypertension,
Show all 10Show fewer
- current pregnancy,
- body mass index <18.5 kg/m2,
- allergy to materials used during the experiment.(e.g. latex),
- known allergies to study drugs
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this investigation is to examine NADPH oxidase as a source of reactive oxygen species contributing to aberrant microvascular function in otherwise healthy women with a history of GDM.
Read the detailed description
Women with a history of gestational diabetes mellitus (GDM) are at a 2-fold greater risk for the development of overt cardiovascular disease (CVD) following the effected pregnancy. While subsequent development of type II diabetes elevates this risk, prior GDM is an independent risk factor for CVD morbidity, particularly within the first decade postpartum. GDM is associated with impaired endothelial function during pregnancy and decrements in macro- and microvascular function persist postpartum, despite the remission of insulin resistance following delivery. Collectively, while the association between GDM and elevated lifetime CVD risk is clear, and available evidence demonstrates a link between GDM and vascular dysfunction in the decade following pregnancy, the mechanisms mediating this persistent dysfunction remain unexamined.
The purpose of this investigation is to examine NADPH oxidase as a source of reactive oxygen species contributing to aberrant microvascular function in otherwise healthy women with a history of GDM.
In this study, the investigators use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) they examine the blood vessels in a dime-sized area of the skin in women who have had GDM. As a compliment to these measures, the investigators also collect endothelial cells from an antecubital vein and measure NADPH oxidase expression and markers of oxidative stress in these cells.
- Being tested
- Acetylcholine, Insulin aspart
- Keywords
- gestational diabetes, postpartum, vascular
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetylcholineDrug
acetylcholine is perfused at 10 ascending concentrations (10^-10M - 10^-1 M) for 5 minutes each
Insulin aspartDrug
insulin aspart is perfused at 5 ascending concentrations (10^-8M - 10^-4 M) for 10 minutes each
| Study group | Role | What they receive |
|---|---|---|
| local lactated Ringer's perfusion | Placebo comparator | lactated Ringer's is perfused through the microdialysis fiber to serve as the vehicle control Receives: Drug: Acetylcholine; Drug: Insulin aspart |
| local apocynin perfusion | Experimental | local apocynin is perfused through the microdialysis fiber to serve as the NADPH oxidase inhibited experimental treatment Receives: Drug: Acetylcholine; Drug: Insulin aspart |
| local L-NAME perfusion | Experimental | local L-NAME is perfused through the microdialysis fiber to inhibit nitric oxide synthase Receives: Drug: Acetylcholine; Drug: Insulin aspart |
| local apocynin + L-NAME perfusion | Experimental | local apocynin and L-NAME are perfused through the microdialysis fiber for dual inhibition of NADPH oxidase and nitric oxide synthase Receives: Drug: Acetylcholine; Drug: Insulin aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
microvascular acetylcholine-mediated dilation
cutaneous vascular vasodilator responses to acetylcholine perfusion in lactated Ringer's, apocynin, L-NAME, and apocynin+L-NAME treated microdialysis sites
Measured: at the study visit, an average of 4 hours
microvascular insulin-mediated dilation
cutaneous vascular vasodilator responses to insulin perfusion in lactated Ringer's, apocynin, L-NAME, and apocynin+L-NAME treated microdialysis sites
Measured: at the study visit, an average of 4 hours
Secondary outcomes (1)
endothelial cell NADPH oxidase expression
NADPH oxidase expression in biopsied endothelial cells
Measured: at the study visit, an average of 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start30 Aug 2023
- Primary completion30 Jun 2026
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anna Stanhewicz, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anna Stanhewicz, PhD, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946798
- Sponsor's protocol ID
- 202303158
- Other IDs
- 1R01HL169201-01
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2023
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of NADPH Oxidase in Microvascular Dysfunction Following GDM
- ClinicalTrials.gov ID
- NCT05946798
- Acronym / sponsor ID
- 202303158
- Keywords
- gestational diabetes, postpartum, vascular
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Anna Stanhewicz, PhDUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this investigation is to examine NADPH oxidase as a source of reactive oxygen species contributing to aberrant microvascular function in otherwise healthy women with a history of GDM.
Detailed description
Women with a history of gestational diabetes mellitus (GDM) are at a 2-fold greater risk for the development of overt cardiovascular disease (CVD) following the effected pregnancy. While subsequent development of type II diabetes elevates this risk, prior GDM is an independent risk factor for CVD morbidity, particularly within the first decade postpartum. GDM is associated with impaired endothelial function during pregnancy and decrements in macro- and microvascular function persist postpartum, despite the remission of insulin resistance following delivery. Collectively, while the association between GDM and elevated lifetime CVD risk is clear, and available evidence demonstrates a link between GDM and vascular dysfunction in the decade following pregnancy, the mechanisms mediating this persistent dysfunction remain unexamined.
The purpose of this investigation is to examine NADPH oxidase as a source of reactive oxygen species contributing to aberrant microvascular function in otherwise healthy women with a history of GDM.
In this study, the investigators use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) they examine the blood vessels in a dime-sized area of the skin in women who have had GDM. As a compliment to these measures, the investigators also collect endothelial cells from an antecubital vein and measure NADPH oxidase expression and markers of oxidative stress in these cells.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| local lactated Ringer's perfusion | Placebo comparator | Drug: Acetylcholine, Drug: Insulin aspartlactated Ringer's is perfused through the microdialysis fiber to serve as the vehicle control |
| local apocynin perfusion | Experimental | Drug: Acetylcholine, Drug: Insulin aspartlocal apocynin is perfused through the microdialysis fiber to serve as the NADPH oxidase inhibited experimental treatment |
| local L-NAME perfusion | Experimental | Drug: Acetylcholine, Drug: Insulin aspartlocal L-NAME is perfused through the microdialysis fiber to inhibit nitric oxide synthase |
| local apocynin + L-NAME perfusion | Experimental | Drug: Acetylcholine, Drug: Insulin aspartlocal apocynin and L-NAME are perfused through the microdialysis fiber for dual inhibition of NADPH oxidase and nitric oxide synthase |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 years or older
- pregnant within 5 years of the study visit
- had gestational diabetes diagnosed by their obstetrician and confirmed according to the American College of Obstetricians and Gynecologists criteria for gestational diabetes.
- or without a history of gestational diabetes
Key exclusion criteria (10 listed)
- skin diseases
- current tobacco or electronic cigarette/vape pen use,
- diagnosed or suspected hepatic or metabolic disease including diabetes,
- statin or other cholesterol-lowering medication,
- current antihypertensive medication,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetylcholineacetylcholine is perfused at 10 ascending concentrations (10^-10M - 10^-1 M) for 5 minutes each | Drug | local L-NAME perfusion, local apocynin + L-NAME perfusion, local apocynin perfusion, local lactated Ringer's perfusion |
| Insulin aspartinsulin aspart is perfused at 5 ascending concentrations (10^-8M - 10^-4 M) for 10 minutes each | Drug | local L-NAME perfusion, local apocynin + L-NAME perfusion, local apocynin perfusion, local lactated Ringer's perfusion |
Primary outcome
microvascular acetylcholine-mediated dilation
Time frame: at the study visit, an average of 4 hours
cutaneous vascular vasodilator responses to acetylcholine perfusion in lactated Ringer's, apocynin, L-NAME, and apocynin+L-NAME treated microdialysis sites
microvascular insulin-mediated dilation
Time frame: at the study visit, an average of 4 hours
cutaneous vascular vasodilator responses to insulin perfusion in lactated Ringer's, apocynin, L-NAME, and apocynin+L-NAME treated microdialysis sites
1 secondary outcome
endothelial cell NADPH oxidase expression
Time frame: at the study visit, an average of 4 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Acetylcholine and Insulin aspart in people with Gestational Diabetes and Oxidative Stress, run by Anna Stanhewicz, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microvascular acetylcholine-mediated dilation (time frame: at the study visit, an average of 4 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.