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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL137087-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antioxidant Cocktail | Dietary Supplement | Vitamin C, Vitamin E, alpha lipoic acid |
|
| Measure | Description | Time Frame |
|---|---|---|
| FMD/Shear | Flow-Mediated Dilation (FMD) controlled for shear | ~ 2 weeks. Acquired at Menses and Late Follicular phase. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Harris, PhD, CES | Augusta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Augusta University | Augusta | Georgia | 30912 | United States | ||
| Georgia Prevention Institute |
These results were based on a subset (n=57) of the total enrollment of 143.
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| ID | Title | Description |
|---|---|---|
| FG000 | T1M Women | women with type 1 diabetes |
| FG001 | Controls | apparently healthy women |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | T1M Women | women with type 1 diabetes |
| BG001 | Controls | apparently healthy women |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | FMD/Shear | Flow-Mediated Dilation (FMD) controlled for shear | Posted | Mean | Standard Deviation | %/s^-1 | ~ 2 weeks. Acquired at Menses and Late Follicular phase. |
|
|
Baseline to Post testing (~2 weeks)
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | T1M Women | women with type 1 diabetes | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ryan Harris | Augusta University | 706-721-5483 | ryharris@augusta.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 14, 2022 | Jan 27, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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| Resveratrol | Dietary Supplement | 1500 mg trans-resveratrol |
|
| Placebo | Other | placebo |
|
| Augusta |
| Georgia |
| 30912 |
| United States |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| MAP | Mean | Standard Deviation | mm Hg |
|
| CRP | C-Reactive Protein | Mean | Standard Deviation | mg/L |
|
| TC | Total Cholesterol | Mean | Standard Deviation | mg/dL |
|
| HDL | Mean | Standard Deviation | mg/dL |
|
| LDL | Mean | Standard Deviation | mg/dL |
|
| TRIG | Triglycerides | Mean | Standard Deviation | mg/dL |
|
| TC/HDL ratio | Mean | Standard Deviation | ratio |
|
| HbA1c | Mean | Standard Deviation | percent |
|
|
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Controls | apparently healthy women | 0 | 25 | 0 | 25 | 0 | 25 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |