An interventional study of Antioxidant Cocktail and Resveratrol in Diabetes Mellitus, Type 1, sponsored by Augusta University. Completed at 2 sites in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-17.
Sponsored by Augusta University · Not applicable, Interventional, and Treatment
Diabetes has recently been referred to as "the epidemic of the 21st century". The reason why women with type 1 diabetes have a 2-3 fold greater risk of cardiovascular disease (CVD) compared to men with type 1 diabetes is unknown.The purpose of this study is to investigate whether or not estrogen contributes to vascular dysfunction in premenopausal women with diabetes.
Exclusion Criteria:
Women with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (Antioxidant cocktail, Resveratrol, or placebo)
Dietary Supplement: Antioxidant Cocktail · Dietary Supplement: Resveratrol · Other: Placebo
Healthy women who participate will receive no intervention and serve as controls.
Men with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (AOX cocktail, Resveratrol, or placebo)
Dietary Supplement: Antioxidant Cocktail · Dietary Supplement: Resveratrol · Other: Placebo
Vitamin C, Vitamin E, alpha lipoic acid
1500 mg trans-resveratrol
placebo
FMD/Shear
Flow-Mediated Dilation (FMD) controlled for shear
Time frame: ~ 2 weeks. Acquired at Menses and Late Follicular phase.
| Milestone | T1M Women | Controls |
|---|---|---|
| Started | 32 | 25 |
| Completed | 32 | 25 |
| Not completed | 0 | 0 |
Flow-Mediated Dilation (FMD) controlled for shear
| %/s^-1 | T1M Women | Controls |
|---|---|---|
| Menses | 0.182 ± 0.068 | 0.206 ± 0.100 |
| Late Follicular | 0.155 ± 0.059 | 0.219 ± 0.110 |
Collected over Baseline to Post testing (~2 weeks). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| T1M Women | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Controls | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Age, Continuous(years) | T1M Women | Controls | Total |
|---|---|---|---|
| Mean | 25 ± 6 | 24 ± 6 | 25 ± 6 |
| Sex: Female, Male(Participants) | T1M Women | Controls | Total |
|---|---|---|---|
| Female | 32 | 25 | 57 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | T1M Women | Controls | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 9 | 11 | 20 |
| White | 23 | 14 | 37 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Height(cm) | T1M Women | Controls | Total |
|---|---|---|---|
| Mean | 163.5 ± 7.0 | 165.4 ± 5.8 | 164.3 ± 6.5 |
| Weight(kg) | T1M Women | Controls | Total |
|---|---|---|---|
| Mean | 72.8 ± 17.6 | 68.4 ± 15.8 | 70.9 ± 16.8 |
| BMI(kg/m^2) | T1M Women | Controls | Total |
|---|---|---|---|
| Mean | 27.2 ± 5.7 | 24.5 ± 4.7 | 26.0 ± 5.4 |
| MAP(mm Hg) | T1M Women | Controls | Total |
|---|---|---|---|
| Mean | 87 ± 8 | 83 ± 7 | 85 ± 8 |
| CRP(mg/L) | T1M Women | Controls | Total |
|---|---|---|---|
| Mean | 5.4 ± 8.3 | 1.2 ± 1.3 | 3.6 ± 6.6 |
6 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Augusta University