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
Among 1,458 studies in Diabetes Mellitus, Type 1 with a site in United States — 191 open to participants now, 259 under way, 17 of them phase 3. Diabetes Mellitus, Type 1 · United States.
Among the 1,458 studies in Diabetes Mellitus, Type 1 with a site in United States, this one is the 247th largest by enrollment of the 1,242 interventional ones that give a count, is one of 74 that started in 2018, is one of 614 with no phase, and was the 839th registered.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
Browse Diabetes Mellitus, Type 1 studies →191 of the 1,458 studies in Diabetes Mellitus, Type 1 with a site in United States are open now. Recruiting first, the newest first:
Emory University · Sites in United States
Ages 31–75 · Healthy volunteers
University of California, Los Angeles · Sites in United States
Ages 18+
Wayne State University · Sites in United States
Ages 16–20
Medtronic MiniMed, Inc. · Sites in United States
Ages 2–80
University of Colorado, Denver · Sites in United States
Ages 10–20
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 411 Diabetes Mellitus, Type 1 studies recruiting now, 128 (31%) set no upper age limit and 257 (63%) stop at 75 or younger; 184 take children under 18; 64 take healthy volunteers.
This study: 18 Years to 40 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,458 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 206 · Phase 2 267 · Phase 3 167 · Phase 4 74
First in 1983; this study’s year is marked. 74 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 143 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Median enrollment 40 across the 1,242 interventional studies, 64 across the 203 observational. Of the 1,117 that completed or were terminated, 563 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
398 of 1,458 have an industry lead sponsor. The 10 most frequent:
Augusta University is the lead sponsor of 180 studies on the registry; 24 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.
Augusta University has 4 studies filed under Diabetes Mellitus, Type 1 — fewer than ten, so there is no comparison to draw.
117 of the studies in Diabetes Mellitus, Type 1 with a site in United States that are under way reach primary completion within a year, 7 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06914895Phase 3Eli Lilly and CompanyA Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT06962280Phase 3Eli Lilly and CompanyA Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT07076199Phase 3Novo Nordisk A/SA Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes | 2027-01-25 |
| NCT06334133Phase 3vTv TherapeuticsCadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes | 2027-04 |
| NCT07056699Phase 3The University of Texas Health Science Center at San AntonioSGLT2i, Pioglitazone, and Ketone Production in T1D | 2027-06-01 |
Add all 117 to your calendar (.ics) → With an account.
Among the 1,458 studies in Diabetes Mellitus, Type 1 with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug pages: Ascorbic Acid · Vitamin E · Thioctic Acid
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.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Apr 2018 to primary completion in Sep 2023, 64 months.
Results were first posted in Feb 2025, 1 year 5 months after primary completion.
Of 844 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's 64 months is above that.
Counting every sponsor, half of 949 studies reached it within 18 months; a quarter within 9 and three quarters within 35.
How these figures are worked out, and which studies are left out of 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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Studies of the drugs tested here: Ascorbic Acid · Vitamin E · Thioctic Acid · Resveratrol