Diabetes Mellitus, Type 1
Conditions
Keywords
Estrogen, Diabetes
Brief 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 vascular dysfunction in premenopausal women with diabetes.
Interventions
DIETARY_SUPPLEMENTAntioxidant Cocktail
Vitamin C, Vitamin E, alpha lipoic acid
DIETARY_SUPPLEMENTResveratrol
1500 mg trans-resveratrol
OTHERPlacebo
placebo
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Augusta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* 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)
Exclusion criteria
* 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) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FMD/Shear | ~ 2 weeks. Acquired at Menses and Late Follicular phase. | Flow-Mediated Dilation (FMD) controlled for shear |
Countries
United States
Participant flow
Pre-assignment details
These results were based on a subset (n=57) of the total enrollment of 143.
Participants by arm
| Arm | Count |
|---|---|
| T1M Women women with type 1 diabetes | 32 |
| Controls apparently healthy women | 25 |
| Total | 57 |
Baseline characteristics
| Characteristic | T1M Women | Controls | Total |
|---|---|---|---|
| Age, Continuous | 25 years STANDARD_DEVIATION 6 | 24 years STANDARD_DEVIATION 6 | 25 years STANDARD_DEVIATION 6 |
| BMI | 27.2 kg/m^2 STANDARD_DEVIATION 5.7 | 24.5 kg/m^2 STANDARD_DEVIATION 4.7 | 26.0 kg/m^2 STANDARD_DEVIATION 5.4 |
| CRP | 5.4 mg/L STANDARD_DEVIATION 8.3 | 1.2 mg/L STANDARD_DEVIATION 1.3 | 3.6 mg/L STANDARD_DEVIATION 6.6 |
| HbA1c | 8.6 percent STANDARD_DEVIATION 1.7 | 5.2 percent STANDARD_DEVIATION 0.3 | 7.1 percent STANDARD_DEVIATION 2.1 |
| HDL | 58 mg/dL STANDARD_DEVIATION 17 | 53 mg/dL STANDARD_DEVIATION 13 | 56 mg/dL STANDARD_DEVIATION 15 |
| Height | 163.5 cm STANDARD_DEVIATION 7 | 165.4 cm STANDARD_DEVIATION 5.8 | 164.3 cm STANDARD_DEVIATION 6.5 |
| LDL | 98 mg/dL STANDARD_DEVIATION 42 | 88 mg/dL STANDARD_DEVIATION 39 | 94 mg/dL STANDARD_DEVIATION 41 |
| MAP | 87 mm Hg STANDARD_DEVIATION 8 | 83 mm Hg STANDARD_DEVIATION 7 | 85 mm Hg STANDARD_DEVIATION 8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 11 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 23 Participants | 14 Participants | 37 Participants |
| Sex: Female, Male Female | 32 Participants | 25 Participants | 57 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| TC | 178 mg/dL STANDARD_DEVIATION 41 | 163 mg/dL STANDARD_DEVIATION 35 | 171 mg/dL STANDARD_DEVIATION 39 |
| TC/HDL ratio | 3.2 ratio STANDARD_DEVIATION 1.1 | 3.2 ratio STANDARD_DEVIATION 0.8 | 3.2 ratio STANDARD_DEVIATION 1 |
| TRIG | 76 mg/dL STANDARD_DEVIATION 45 | 63 mg/dL STANDARD_DEVIATION 28 | 70 mg/dL STANDARD_DEVIATION 39 |
| Weight | 72.8 kg STANDARD_DEVIATION 17.6 | 68.4 kg STANDARD_DEVIATION 15.8 | 70.9 kg STANDARD_DEVIATION 16.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 25 |
| other Total, other adverse events | 0 / 32 | 0 / 25 |
| serious Total, serious adverse events | 0 / 32 | 0 / 25 |
Outcome results
Primary
FMD/Shear
Flow-Mediated Dilation (FMD) controlled for shear
Time frame: ~ 2 weeks. Acquired at Menses and Late Follicular phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| T1M Women | FMD/Shear | Menses | 0.182 %/s^-1 | Standard Deviation 0.068 |
| T1M Women | FMD/Shear | Late Follicular | 0.155 %/s^-1 | Standard Deviation 0.059 |
| Controls | FMD/Shear | Menses | 0.206 %/s^-1 | Standard Deviation 0.1 |
| Controls | FMD/Shear | Late Follicular | 0.219 %/s^-1 | Standard Deviation 0.11 |