Diabetes Mellitus, Type 1NCT03436992
Estrogen and Diabetes
A study testing Antioxidant Cocktail and Resveratrol in people with Diabetes Mellitus, Type 1, run by Augusta University at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Antioxidant Cocktail and Resveratrol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Apr 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both men and premenopausal
- 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)
Who cannot join
- Clinical diagnosis of hepatic, cardiovascular, or renal disease
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Augusta University
Augusta, Georgia, 30912
Georgia Prevention Institute
Augusta, Georgia, 30912
About this study
Official title: Estrogen-Mediated Impairments of Vascular Health in Diabetes
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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Antioxidant Cocktail, Resveratrol, Placebo
- Keywords
- Estrogen, Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antioxidant CocktailDietary supplement
Vitamin C, Vitamin E, alpha lipoic acid
ResveratrolDietary supplement
1500 mg trans-resveratrol
PlaceboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| Women with type 1 diabetes | Experimental | Women with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (Antioxidant cocktail, Resveratrol, or placebo) Receives: Dietary Supplement: Antioxidant Cocktail; Dietary Supplement: Resveratrol; Other: Placebo |
| Healthy control women | No intervention | Healthy women who participate will receive no intervention and serve as controls. |
| Men with type 1 diabetes | Experimental | Men with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (AOX cocktail, Resveratrol, or placebo) Receives: Dietary Supplement: Antioxidant Cocktail; Dietary Supplement: Resveratrol; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
FMD/Shear
Flow-Mediated Dilation (FMD) controlled for shear
Measured: ~ 2 weeks. Acquired at Menses and Late Follicular phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start17 Apr 2018
- Primary completion1 Sep 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Ryan Harris, Augusta University
- Investigators
- Ryan Harris, PhD, CES, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436992
- Sponsor's protocol ID
- E2 and D
- Other IDs
- 1R01HL137087-01A1
- Status last verified
- Jan 2025
- First submitted
- 13 Feb 2018
- Last updated
- 17 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estrogen-Mediated Impairments of Vascular Health in Diabetes
- ClinicalTrials.gov ID
- NCT03436992
- Acronym / sponsor ID
- E2 and D
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Estrogen, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Posted 17 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Women with type 1 diabetes | Experimental | Dietary Supplement: Antioxidant Cocktail, Dietary Supplement: Resveratrol, Other: PlaceboWomen with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (Antioxidant cocktail, Resveratrol, or placebo) |
| Healthy control women | No intervention | –Healthy women who participate will receive no intervention and serve as controls. |
| Men with type 1 diabetes | Experimental | Dietary Supplement: Antioxidant Cocktail, Dietary Supplement: Resveratrol, Other: PlaceboMen with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (AOX cocktail, Resveratrol, or placebo) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both men and premenopausal
- 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)
Key exclusion criteria (12 listed)
- Clinical diagnosis of hepatic, cardiovascular, or renal disease
- Uncontrolled Diabetes (HbA1c>9%)
- Diabetic complications (i.e. macrovascular, microvascular, or autonomic)
- Proteinuria
- Uncontrolled Hypertension (>140/90 mmHg on therapy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antioxidant CocktailVitamin C, Vitamin E, alpha lipoic acid | Dietary supplement | Men with type 1 diabetes, Women with type 1 diabetes |
| Resveratrol1500 mg trans-resveratrol | Dietary supplement | Men with type 1 diabetes, Women with type 1 diabetes |
| Placeboplacebo | Other | Men with type 1 diabetes, Women with type 1 diabetes |
Primary outcome
FMD/Shear
Time frame: ~ 2 weeks. Acquired at Menses and Late Follicular phase.
Flow-Mediated Dilation (FMD) controlled for shear
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Diabetes Mellitus, Type 1
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
RecruitingPhase 3
A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus
Obesity or Overweight
Not yet recruitingPhase 1/2
Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Sarcomas
Sarcoma, Osteoid Sarcoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Harris, PhD, CES principal investigator
Augusta University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antioxidant Cocktail and Resveratrol in people with Diabetes Mellitus, Type 1, run by Augusta University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FMD/Shear (time frame: ~ 2 weeks. Acquired at Menses and Late Follicular phase.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.