Ignite Creation Date:
2024-05-06 @ 9:43 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03056014
Status:
TERMINATED
Last Update Posted:
2022-03-22
First Post:
2017-01-30
Brief Title:
Antioxidant Use in Diabetes to Reduce Oxidative Stress
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Supplementation of N-acetylcysteine and Arachonic Acid in Type 1 Diabetes to Determine Changes in Oxidative Stress
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
COVID
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 AcidsPUFA 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 mgday Group 2 NAC 1200 mgday and Group 3 NAC 1800 mgday 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 mgday or Group 2 2000 mgday or Group 3placebo 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 NACPUFA 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
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 mgday or Group 2 2000 mgday or Group 3placebo 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 NACPUFA 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None