Study Results
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View full resultsBasic Information
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COMPLETED
NA
143 participants
INTERVENTIONAL
2018-04-17
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Women with type 1 diabetes
Women with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (Antioxidant cocktail, Resveratrol, or placebo)
Antioxidant Cocktail
Vitamin C, Vitamin E, alpha lipoic acid
Resveratrol
1500 mg trans-resveratrol
Placebo
placebo
Healthy control women
Healthy women who participate will receive no intervention and serve as controls.
No interventions assigned to this group
Men with type 1 diabetes
Men with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (AOX cocktail, Resveratrol, or placebo)
Antioxidant Cocktail
Vitamin C, Vitamin E, alpha lipoic acid
Resveratrol
1500 mg trans-resveratrol
Placebo
placebo
Interventions
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Antioxidant Cocktail
Vitamin C, Vitamin E, alpha lipoic acid
Resveratrol
1500 mg trans-resveratrol
Placebo
placebo
Eligibility Criteria
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Inclusion Criteria
* Normal menstrual cycle interval of 25-35 days for at least 3 previous cycles
* All races
* Clinical diagnosis of insulin-dependent type 1 diabetes (patients only)
Exclusion Criteria
* Uncontrolled Diabetes (HbA1c\>9%)
* Diabetic complications (i.e. macrovascular, microvascular, or autonomic)
* Proteinuria
* Uncontrolled Hypertension (\>140/90 mmHg on therapy)
* Hormonal use of birth control (past 3 months)
* Pregnancy
* Oligomenorrhea
* Direct vasoactive medications (i.e. nitrates)
* Anti-estrogens (i.e. SERMs)
* Plycystic ovarian syndrome (defined by NIH guidelines-hyperandrogenic anovulation)
* Undetectable Anti-Mullerian Hormone (AMH) following screening
18 Years
40 Years
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Augusta University
OTHER
Responsible Party
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Ryan Harris
Associate Professor
Principal Investigators
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Ryan Harris, PhD, CES
Role: PRINCIPAL_INVESTIGATOR
Augusta University
Locations
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Augusta University
Augusta, Georgia, United States
Georgia Prevention Institute
Augusta, Georgia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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E2 and D
Identifier Type: -
Identifier Source: org_study_id
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