Purpose

Dietary supplementation with antioxidant vitamins, such as Vitamin C and Vitamin E, reduces malformation rates in embryos of diabetic animals. However, human trials exploring the benefits of these antioxidant vitamins have produced unsatisfactory results in trials designed to alleviating diabetic retinopathy, cardiovascular disease, and preeclampsia in pregnancies. The investigators hypothesize that more potent, and better-targeted antioxidants, such as N-acetylcysteine (NAC) and Polyunsaturated Fatty Acids(PUFA), will be successful in preventing birth defects in the offspring of women with diabetes.

Condition

Eligibility

Eligible Ages
Between 18 Years and 44 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • hemoglobin a1c <10
  • type 1 diabetes

Exclusion Criteria

  • pregnancy
  • BMI > 40
  • greater than 1 alcoholic beverages per week
  • any tobacco use
  • prescribed nitroglycerin, HIV protease inhibits, corticosteroids, cephalosporins, or blood thinners
  • vascular complications(history of coronary artery disease, cerebral vascular accident, transient ischemic attack, claudication).

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)
Masking Description
Double blind

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
N-acetylcysteine 600 mg
  • Drug: N-acetyl cysteine
    giving varying doses of NAC in order to determine which reduces oxidative stress.
Active Comparator
N-acetylcysteine 1200 mg
  • Drug: N-acetyl cysteine
    giving varying doses of NAC in order to determine which reduces oxidative stress.
Placebo Comparator
placebo
  • Dietary Supplement: Placebo
    L-alanine placebo pill to determine if effect is supplement related or random effect.
Active Comparator
PUFA 1000 mg
  • Dietary Supplement: omega 6 Fish oil ( PUFA)
    giving varying doses of PUFA in order to determine which reduces oxidative stress.
Active Comparator
PUFA 2000 mg
  • Dietary Supplement: omega 6 Fish oil ( PUFA)
    giving varying doses of PUFA in order to determine which reduces oxidative stress.
Placebo Comparator
Placebo
  • Dietary Supplement: Placebo
    L-alanine placebo pill to determine if effect is supplement related or random effect.

Recruiting Locations

University of Maryland, Baltimore
Baltimore, Maryland 21201
Contact:
Sarah D Crimmins, DO
410-328-5960
scrimmins@fpi.umaryland.edu

More Details

NCT ID
NCT03056014
Status
Recruiting
Sponsor
University of Maryland

Study Contact

Caroline Pancotti
4103287791
cpancotti@fpi.umaryland.edu

Detailed Description

Specific Aim 1. Recruit non pregnant women with T1DM and investigate the efficacy of dietary NAC on ameliorating oxidative stress Study design. Diabetic patients will be provided with NAC or placebo for 14 days, while receiving usual clinical care. The oxidative stress status will be assessed by measuring biomarkers in blood samples pre and post intervention. In addition to a placebo control group, three treatment groups including Group 1 (NAC 600 mg/day), Group 2 (NAC 1200 mg/day), and Group 3 (NAC 1800 mg/day) will be studied. The choice of dosage of NAC is based on published studies, which show effectiveness of NAC in 600 or 1200 mg day in alleviating oxidative stress in diabetic patients, both in men and women, without adverse side effects. The investigators will use the supplement company TwinLab for our study. The university of Maryland Pharmacy department will analyze the NAC for purity prior to starting the study. At day 7, participants will be called via phone assess for symptoms and side effects from medications. All participants will be called. At the end of 14 days, the patients will return to the CDE with a survey asking about compliance with medication and any side effects. They will also bring the pill bottle so that study personnel can do a pill count. At this time blood will be draw for the biomarker levels to look for changes in oxidative stress.

Specific Aim 2. To investigate effect of PUFAs on ameliorating oxidative stress in diabetic non-pregnant women.

Study design: The investigators will recruit a new group of Non-pregnant women with T1DM will be enrolled and randomly assigned to placebo or one of three treatment groups. Study volunteers will be divided into 1 of 3 groups. PUFA; Group 1 (1000 mg/day) or Group 2 (2000 mg/day) or Group 3(placebo). The treatment regimens, sample collection, biomarker assessment, side effect monitoring and statistical analysis will be performed as described in SA 1. The investigators will perform an analysis of the oxidative stress biomarkers as described in SA1. The investigators will use TwinLab as our commercial supplier of PUFA for our trial. There fish oil supplements have been involved in greater than 40 published trials. The fish oil supplement will be analyzed by the University of Maryland pharmacy department prior to starting the study to analyze for purity.

Specific Aim 3: To investigate the potential secondary benefit of NAC/PUFA on kidney function and lipid profile. Urine and serum samples will be collected on all enrolled subjects at day 0 and Day 14 to monitor for improvement in microalbumin in the urine and lipid profile in the serum. Previous studies have shown improvements in LDL with supplementation of NAC. The investigators will look at how various dosages effect the improvement in microalbumin and lipid profile.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.