Antioxidant Use in Diabetes to Reduce Oxidative Stress

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ClinicalTrials.gov Identifier: NCT03056014

Recruitment Status : Not yet recruiting

First Posted : February 16, 2017

Last Update Posted : February 5, 2018

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Sponsor:

Information provided by (Responsible Party):

Sarah Crimmins, University of Maryland

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ameliorating Oxidative Stress in Type 1 Diabetes	Drug: N-acetyl cysteine Dietary Supplement: omega 6 Fish oil ( PUFA) Dietary Supplement: Placebo	Early Phase 1

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 Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	126 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Masking Description:	Double blind
Primary Purpose:	Treatment
Official Title:	Supplementation of N-acetylcysteine and Arachonic Acid in Type 1 Diabetes to Determine Changes in Oxidative Stress
Estimated Study Start Date :	May 2018
Estimated Primary Completion Date :	June 2018
Estimated Study Completion Date :	June 2020

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Type 1 diabetes

MedlinePlus related topics: Antioxidants Diabetes Type 1

Drug Information available for: Acetylcysteine

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 44 Years (Adult)
Sexes Eligible for Study:	Female
Gender Based Eligibility:	Yes
Gender Eligibility Description:	we specifically want to study this in reproductive age females.
Accepts Healthy Volunteers:	Yes

Criteria

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).

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056014

Contacts


Contact: Caroline Pancotti	4103287791	cpancotti@fpi.umaryland.edu

Sponsors and Collaborators

University of Maryland

More Information


Responsible Party:	Sarah Crimmins, Assistant Professor, University of Maryland
ClinicalTrials.gov Identifier:	NCT03056014 History of Changes
Other Study ID Numbers:	HP-00067782
First Posted:	February 16, 2017 Key Record Dates
Last Update Posted:	February 5, 2018
Last Verified:	February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No


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

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Acetylcysteine N-monoacetylcystine Antiviral Agents	Anti-Infective Agents Expectorants Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antidotes

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