Antioxidant Use in Diabetes to Reduce Oxidative Stress

NCT03056014 | Terminated Early Phase 1 DMC FDA Drug

• 1 other identifier: HP-00067782
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Ameliorating Oxidative Stress in Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

• Change from baseline in level of oxidative stress with varying doses of NAC at 2 weeks.

  2 weeks

• Change from baseline in level of oxidative stress with varying doses of omega 6 fish oil(PUFA) at 2 weeks.

  2 weeks

Study Arms (6)

N-acetylcysteine 600 mg

ACTIVE COMPARATOR

Drug: N-acetyl cysteine

N-acetylcysteine 1200 mg

ACTIVE COMPARATOR

Drug: N-acetyl cysteine

placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

PUFA 1000 mg

ACTIVE COMPARATOR

Dietary Supplement: omega 6 Fish oil ( PUFA)

PUFA 2000 mg

ACTIVE COMPARATOR

Dietary Supplement: omega 6 Fish oil ( PUFA)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

N-acetyl cysteine DRUG

giving varying doses of NAC in order to determine which reduces oxidative stress.

N-acetylcysteine 1200 mg; N-acetylcysteine 600 mg

omega 6 Fish oil ( PUFA) DIETARY_SUPPLEMENT

giving varying doses of PUFA in order to determine which reduces oxidative stress.

PUFA 1000 mg; PUFA 2000 mg

Placebo DIETARY_SUPPLEMENT

L-alanine placebo pill to determine if effect is supplement related or random effect.

Placebo; placebo

Eligibility Criteria

• Age: 18 Years - 44 Years
• Gender Eligibility Details: we specifically want to study this in reproductive age females.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• hemoglobin a1c \<10
• type 1 diabetes

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Interventions

Acetylcysteine; Fatty Acids, Unsaturated

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 16, 2017
• Study Start: November 1, 2018
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)