- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03056014
Antioxidant Use in Diabetes to Reduce Oxidative Stress
Supplementation of N-acetylcysteine and Arachonic Acid in Type 1 Diabetes to Determine Changes in Oxidative Stress
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland, Baltimore
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
L-alanine placebo pill to determine if effect is supplement related or random effect.
|
Placebo Comparator: placebo
|
L-alanine placebo pill to determine if effect is supplement related or random effect.
|
Active Comparator: N-acetylcysteine 600 mg
|
giving varying doses of NAC in order to determine which reduces oxidative stress.
|
Active Comparator: N-acetylcysteine 1200 mg
|
giving varying doses of NAC in order to determine which reduces oxidative stress.
|
Active Comparator: PUFA 1000 mg
|
giving varying doses of PUFA in order to determine which reduces oxidative stress.
|
Active Comparator: PUFA 2000 mg
|
giving varying doses of PUFA in order to determine which reduces oxidative stress.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in level of oxidative stress with varying doses of NAC at 2 weeks.
Time Frame: 2 weeks
|
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
|
2 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Immune System Diseases
- Autoimmune Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Protective Agents
- Respiratory System Agents
- Antioxidants
- Antidotes
- Free Radical Scavengers
- Expectorants
- Acetylcysteine
- N-monoacetylcystine
Other Study ID Numbers
- HP-00067782
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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