CLINICAL TRIAL

N acetyl cysteine + vagus nerve stimulation for Pregnancy in Diabetics

Recruiting · < 18 · All Sexes · Charleston, SC

This study is evaluating whether an antioxidant may help improve oral feeding in infants of diabetic mothers.

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About the trial for Pregnancy in Diabetics

Eligible Conditions
Feeding and Eating Disorders · Fetal Diseases · Pregnancy in Diabetics · Infants of Diabetic Mothers · Feeding Disorders · Stress Oxidative · Vagus Nerve Stimulation

Treatment Groups

This trial involves 2 different treatments. N Acetyl Cysteine + Vagus Nerve Stimulation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
N acetyl cysteine + vagus nerve stimulation
COMBINATIONPRODUCT
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and younger. There is one eligibility criterion to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Infants of diabetic mothers who are failing oral feeding, >39weeks gestation at enrollment, who are clinically stable, on minimal respiratory support (nasal cannula or room air), and clinical team has determined are G-tube candidates
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 20 days
Screening: ~3 weeks
Treatment: Varies
Reporting: 20 days
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 20 days.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether N acetyl cysteine + vagus nerve stimulation will improve 1 primary outcome, 1 secondary outcome, and 1 other outcome in patients with Pregnancy in Diabetics. Measurement will happen over the course of 14 days.

Diffusion Kurtosis Imaging (DKI)
14 DAYS
DKI metrics in white matter tracts before and after NAC+taVNS treatment
14 DAYS
Metabolite concentrations in basal ganglia
14 DAYS
[GSH] and other CNS metabolites by MRS before, and after 3-4 days of NAC and after NAC+taVNS treatment
14 DAYS
Daily oral feeding volumes
20 DAYS
ml/kg/d of oral feeds, slope of change of oral feeding volumes before and after NAC + taVNS
20 DAYS

Who is running the study

Principal Investigator
D. D. J.
Prof. Dorothea D. Jenkins, Professor of Pediatrics
Medical University of South Carolina

Patient Q & A Section

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

How many people get pregnancy in diabetics a year in the United States?

The rate of pregnancy in diabetics is increasing because of women's desire and better knowledge of pregnancy complications. Pregnant diabetic women are more likely to have a first birth. More women are also delaying the start of treatment with a long time interval from the first prenatal visit.

Anonymous Patient Answer

What causes pregnancy in diabetics?

Diabetes and smoking cause the vast majority of pregnancy complications in diabetics. Diabetes is an underlying factor of impaired trophoblast function that might be related with the high prevalence of embryo loss and pregnancy complications. Smoking is a high risk factor for impaired trophoblast function.

Anonymous Patient Answer

What is pregnancy in diabetics?

Insulin, when used for treatment of pregnancy diabetes, is safe in terms of both maternal and fetal health. Furthermore, pregnancy in diabetics is an acceptable and safe option for diabetic patients considering that the maternal health outcomes are very good in comparison with the general population.

Anonymous Patient Answer

What are common treatments for pregnancy in diabetics?

A number of treatments are used for pregnancy in diabetics. The use of these treatments is reliant on how far along a pregnancy the mother has gestated and also depends on the comorbid conditions of the mother. Although some of the treatments, such as diet, exercise, and oral hypoglycemic agents can be beneficial for gestational diabetics, most of the treatments are ineffective and should be only considered when the pregnant woman has had a serious underlying medical condition leading to poor prognosis.

Anonymous Patient Answer

Can pregnancy in diabetics be cured?

There are several treatments that can be used in women with diabetes that have a risk of adverse obstetric and perinatal outcomes. The data are limited. The available evidence points towards the need to treat diabetic women with an effective method that will maintain an adequate fetal weight and fetal heart rate. Given the importance of fetal wellbeing, optimal pregnancy treatment should be based on fetal monitoring. In the first trimester, women may be managed on an anticonvulsant drug regimen which has shown to be efficacious and well tolerated with no apparent adverse maternal and fetal outcomes.

Anonymous Patient Answer

What are the signs of pregnancy in diabetics?

Results from a recent paper summarizes useful clinical signs and symptomatology, besides routine laboratory investigation, which can be used to anticipate imminent pregnancy complication in diabetics and to predict pregnancy outcome.

Anonymous Patient Answer

What is the primary cause of pregnancy in diabetics?

There has been a tendency for pregnant diabetics to have been more likely to report multiple births, increased fetal weight, large amniotic fluid, pre-eclampsia, gestational complications and have had a previous stillborn baby. There was a higher percentage of diabetic pregnancies in those with a high socioeconomic level. Overall in this cohort the risk of pre-eclampsia appeared to be approximately 1.4 times greater, gestational diabetes appears to have a 2.9 fold increased risk, and fetal abnormalities such as macrosomia, fetal growth restriction and structural anomalies appeared to be approximately 1.8 times greater, all compared to a nondiabetic.

Anonymous Patient Answer

What are the common side effects of n acetyl cysteine + vagus nerve stimulation?

The combination is well tolerated, but side effects of NAC are not uncommon. The observed side effects are predictable. These side effects include nausea, vomiting, rash, dizziness, and headache.

Anonymous Patient Answer

Is n acetyl cysteine + vagus nerve stimulation safe for people?

Our pilot study found few patients suffering from serious adverse events when NAC in combination with VNS is used. Although our study has only a short duration (eight weeks), the safety and effectiveness of long-term VNS + NAC remain to be established.

Anonymous Patient Answer

Have there been any new discoveries for treating pregnancy in diabetics?

There has not been any new information about the latest advancements on how to care for mothers and babies during diabetes pregnancy. Diabetes-associated pregnancy complications include preeclampsia, gestational diabetes, and gestational hypertension. The most important considerations for this patient group are the management of [glycemia, lipids, hemodynamics, and pregnancy complications] during their pregnancy and after [pregnancy] in order to [help diminish the effects of diabetes mellitus on fertility, placentation and childbirth, and pregnancy outcome.

Anonymous Patient Answer

How does n acetyl cysteine + vagus nerve stimulation work?

This trial shows that combining the anti-oxidative medication nacetyl cysteine and VNS did not improve seizure duration nor modify EEG characteristics in women with partial refractory epilepsy and mild cognitive impairment.

Anonymous Patient Answer

Does pregnancy in diabetics run in families?

Diabetes is a familial disease and a common occurrence within the diabetic population. The effect of type 1 and [type 2 diabetes](https://www.withpower.com/clinical-trials/type-2-diabetes) is not only on the unborn fetus but could also damage the future development of this generation and that of the next.

Anonymous Patient Answer
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