Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
EARLY_PHASE1
8 participants
INTERVENTIONAL
2018-11-01
2020-03-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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N-acetylcysteine 600 mg
N-acetyl cysteine
giving varying doses of NAC in order to determine which reduces oxidative stress.
N-acetylcysteine 1200 mg
N-acetyl cysteine
giving varying doses of NAC in order to determine which reduces oxidative stress.
placebo
Placebo
L-alanine placebo pill to determine if effect is supplement related or random effect.
PUFA 1000 mg
omega 6 Fish oil ( PUFA)
giving varying doses of PUFA in order to determine which reduces oxidative stress.
PUFA 2000 mg
omega 6 Fish oil ( PUFA)
giving varying doses of PUFA in order to determine which reduces oxidative stress.
Placebo
Placebo
L-alanine placebo pill to determine if effect is supplement related or random effect.
Interventions
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N-acetyl cysteine
giving varying doses of NAC in order to determine which reduces oxidative stress.
omega 6 Fish oil ( PUFA)
giving varying doses of PUFA in order to determine which reduces oxidative stress.
Placebo
L-alanine placebo pill to determine if effect is supplement related or random effect.
Eligibility Criteria
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Inclusion Criteria
* type 1 diabetes
Exclusion Criteria
* 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).
18 Years
44 Years
FEMALE
Yes
Sponsors
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University of Maryland, Baltimore
OTHER
Responsible Party
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Sarah Crimmins
Assistant Professor
Locations
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University of Maryland, Baltimore
Baltimore, Maryland, United States
Countries
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Other Identifiers
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HP-00067782
Identifier Type: -
Identifier Source: org_study_id
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