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Antioxidant Use in Diabetes to Reduce Oxidative Stress

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ClinicalTrials.gov Identifier: NCT03056014
Recruitment Status : Active, not recruiting
First Posted : February 16, 2017
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Sarah Crimmins, University of Maryland, College Park

Tracking Information
First Submitted Date  ICMJE January 30, 2017
First Posted Date  ICMJE February 16, 2017
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE November 1, 2018
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2017)
  • Change from baseline in level of oxidative stress with varying doses of NAC at 2 weeks. [ Time Frame: 2 weeks ]
  • Change from baseline in level of oxidative stress with varying doses of omega 6 fish oil(PUFA) at 2 weeks. [ Time Frame: 2 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antioxidant Use in Diabetes to Reduce Oxidative Stress
Official Title  ICMJE Supplementation of N-acetylcysteine and Arachonic Acid in Type 1 Diabetes to Determine Changes in Oxidative Stress
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description:
Double blind
Primary Purpose: Treatment
Condition  ICMJE Ameliorating Oxidative Stress in Type 1 Diabetes
Intervention  ICMJE
  • Drug: N-acetyl cysteine
    giving varying doses of NAC in order to determine which reduces oxidative stress.
  • Dietary Supplement: omega 6 Fish oil ( PUFA)
    giving varying doses of PUFA in order to determine which reduces oxidative stress.
  • Dietary Supplement: Placebo
    L-alanine placebo pill to determine if effect is supplement related or random effect.
Study Arms  ICMJE
  • Active Comparator: N-acetylcysteine 600 mg
    Intervention: Drug: N-acetyl cysteine
  • Active Comparator: N-acetylcysteine 1200 mg
    Intervention: Drug: N-acetyl cysteine
  • Placebo Comparator: placebo
    Intervention: Dietary Supplement: Placebo
  • Active Comparator: PUFA 1000 mg
    Intervention: Dietary Supplement: omega 6 Fish oil ( PUFA)
  • Active Comparator: PUFA 2000 mg
    Intervention: Dietary Supplement: omega 6 Fish oil ( PUFA)
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 13, 2017)
126
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2, 2024
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: we specifically want to study this in reproductive age females.
Ages  ICMJE 18 Years to 44 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03056014
Other Study ID Numbers  ICMJE HP-00067782
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sarah Crimmins, University of Maryland, College Park
Study Sponsor  ICMJE University of Maryland, Baltimore
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Maryland, Baltimore
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP